GYMA

Finished Product List

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Dosage Form Filing Strategy

Abiraterone Acetate

Zytiga

Janssen Biotech

250 mg

4/28/2011

chemotherapy

Tablet

PIV

Adapalene

Differin

Galderma Labs

0.1%

5/26/2000

anti-acne

Semi-Solid

PI

Afatinib Dimaleate

Gilotrif

Boehringer Ingelheim

20, 30 and 40 mg

7/12/2013

anti-cancer

Tablet

PIV

Alogliptin Benzoate

Nesina

Takeda Pharms

6.25, 12.5 and 25 mg

1/25/2013

anti-diabetic

Tablet

FTF/PIV

Alprazolam

Xanax

Pharmacia

0.25, 0.5, 1 and 2 mg

Prior to 1982

anti-anxiety

Tablet

PI

Ambrisentan

Letairis

Gilead

5mg

6/15/2007

anti-hypertensive

Tablet

PIV

Apixaban

Eliquis

BMS

2.5 and 5 mg

12/28/2012

anti-coagulate

Tablet

FTF/PIV

Aripiprazole

Abilify

Otsuka

2, 5, 10, 15, 20 and 30 mg

10/15/2002

anti-psychotic

Tablet

PIV

Azithromycin

Azithromax

Pfizer

250, 500 and 600 mg

6/12/1996

anti-infective

Tablet

PI

Azithromycin

Zithromax

Pharmacia

100mg/5mL Base 200mg/5mL 1 Gram/packet

10/19/1995

anti-infective

Suspension

PIV

corticosteroid

Semi-Solid

NDA/505b2

Beclometasone Dipropionate

0.025%

Bendamustine HCl

Treanda

Betamethasone Dipropionate

Cephalon

25mg and 100mg/vial

3/20/2008

chemotherapy

Powder/IV

PIV

Betamethasone Dipropionate

Fougera

0.05%

6/26/1984

anti-inflammatory

Semi-Solid

PI

Betamethasone Valerate

Betamethasone Valerate

Fougera

0.10%

8/31/1983

anti-inflammatory

Semi-Solid

PI

Bivalirudin

Angiomax

Medicines

250 mg

12/15/2000

anti-hypertensive

Injectable

PIV

Bortezomib

Velcade

Millennium Pharm

3.5mg

5/13/2003

anti-neoplastic

Injectable

PIV

Brinzolomide

Azopt

Alcon

1.00%

4/1/1998

anti-glaucoma

Ophthalmic

PI

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Alcon

1%/0.2%

4/19/2013

anti-glaucoma

Ophthalmic

PIV

US Pharms

2.5 mg

Prior to 1982

anti-diabetic

Tablets

PI

Hoffmann LA Roche

150 and 500 mg

4/30/1998

anti-neoplastic

Tablet

PI

Dosage Form Filing Strategy

Brinzolomide/Brimonidine Tartrate

Simbrinza

Bromocriptine Mesilate

Parlodel

Capecitabine

Xeloda

Carfilzomib

Kyprolis

Onyx Pharms

60 mg/vial

7/20/2012

proteasome inhibitor

Injectable

PIV/FTF

Cephalexin

Keflex

Shionogi Inc.

250, 500 and 750 mg

Prior to 1982

anti-infective

Tablet

PI

Clevidipine Butyrate

Cleviprex

Medicines

25mg/50mL and 50mg/100mL

8/1/2008

anti-hypertensive

Emulsion/IV

PIV

Clobazam

Onfi

Lunbeck LLC

10 and 20 mg

10/21/2011

benzodiazepine

Tablet

FTF

Clobetasol Propionate

Temovate

Fougera

0.05%

12/27/1985

corticosteroid

Semi-Solid

PI

Clonazepam

Klonopin

Roche

0.5, 1 and 2 mg

Prior to 1982

anti-convulsants

Tablet

PI

Clotrimazole

Clotrimazole

Taro

1%

8/31/1993

anti-fungal

Semi-Solid

PI

Colistimethate Sodium

Coly-Mycin M

JHP

EQ 150 mg

Prior to 1982

anti-infective

Injectable

PI

Corticotropin

H.P Acthar

Questcor

80 units/mL

Prior to 1982

ACTH, MS

Injectable

PIV

Cyclosporin

Restasis

Allergan

0%

12/23/2002

anti-inflammatory

Ophthalmic

PIV

Dabigatran Etexilate Mesylate

Pradaxa

BI

75 and 150 mg

10/19/2010

thrombin inhibitor

Capsule

PIV

Dasatinib

Sprycel

BMS

20, 50 and 70mg

6/28/2006

anti-neoplastic

Tablet

PIV

Decitabine

Dacogen

Eisai

50 mg

5/2/2006

anti-neoplastic

Injectable

PI

Deferasirox

Exjade

Novartis

125, 250 and 500 mg

11/2/2005

chelating agent

Tablet for Suspension

PIV

Degarelix Acetate

Firmagon

Ferring

80 and 120mg Base/Vial

12/24/2008

anti-neoplastic

Powder/ Injectable

PIV

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Dosage Form Filing Strategy

Desvenlafaxine HCl

Desvenlafaxine

Alembic

50 and 100 mg

3/4/2013

anti-psychotic

Tablet

PI

Dexlansoprazole

Dexilant

Takeda

30 and 60 mg

1/30/2009

anti-ulcer

Capsule

PIV

Dipyridamole/Aspirin

Aggrenox

BI

25mg/200mg

11/22/1999

antiplatelet

Capsule ER

PIV

Entecavir

Baraclude

BMS

0.5 and 1 mg

3/29/2005

Nucleoside analogue reverse transcriptase inhibitor

Tablet

PIII

Enzalutamide

Xtandi

Astellas

40 mg

8/31/2012

androgen receptor inhibitor

Capsule

PIV/FTF

Erlotinib HCl

Tarceva

OSI Pharm

25, 100 and 150 mg

11/18/2004

anti-cancer

Tablet

PIV

Escitalopram Oxalate

Lexapro

Forest Labs

5, 10 and 20 mg

8/14/2002

anti-psychotic

Tablet

PI

Ezetimib

Zetia

MSD Intl Gmbh

10mg

10/25/2002

anti-lipemic

Tablets

PIV

Ferumoxytol

Feraheme

Amag Pharms Inc.

EQ 510 Iron

6/30/2009

hematinic

Solution; IV

PIV

Fluticasone Propionate

Fluticasone Propionate

Fougera

0.05%

various

corticosteroid

Semi-Solid

PI

Fluticasone Propionate/ Salmeterol Xinafoate

Advair Diskus

Glaxo Grp

0.1mg; EQ 0.05mg Base/INH 0.25mg; 0.05mg Base/INH 0.5mg; 0.05 mg Base/INH

various

corticosteroid

Inhalation

PIII

Fosaprepitant Dimeglumine

Emend

Merck & Co

EQ 150mg Base/Vial

11/12/2010

anti-emetic

Injectable

PIV/505b2

Foscarnet Sodium

Foscavir

Clinigen Healthcare

2.4gm/100mL

9/27/1991

anti-viral

Injectable

PI

Fulvestrant

Faslodex

AstraZeneca

50mg/mL

4/25/2002

anti-estrogen

Injectable

PIV

anti-inflammatory

Semi-Solid

NDA

Hydrocortisone Acetate

1.00%

Ibuprofen

Caldolol

Icatibant Acetate Imatinib

Cumberland Pharm

800mg/8mL

6/11/2009

analgesia/antipyretic

Injectable

PIV

Firazyr

Shire

EQ 30mg Base/3mL

8/25/2011

bradykinin B2 receptor antagonist.

Injectable/PFS

PIV

Gleevec

Novartis

100 and 400 mg

4/18/2003

anti-neoplastic

Tablet

PIV

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Dosage Form Filing Strategy

Imiquimod

Aldara

Medics

5%

2/27/1997

immune modulator

Semi-Solid

PI

Imiquimod

Zyclara

Medics

3.75%

3/25/2010

immune modulator

Semi-Solid

PIV

Lenalidomide

Revlimid

Celgene

5, 10, 15 and 25 mg

12/27/2005

anti-neoplastic

Capsule

PIV

Leuprolide Acetate

Leuprolide Acetate

Sandoz

1mg/0.2mL

8/4/1998

hormone replacement

Injectable

PI

Levothyroxine Sodium

Levothyroxine Sodium

Fresenius Kabi

1100mcg/vial, 200mcg/vial and 500 mcg/vial

6/24/2011

Synthetic thyroxine hormone

Injectable

PI

Linaclotide

Linzess

Forest Labs

145 and 290 mcg

8/30/2012

guanylate cyclase C agonist (IBS-C)

Capsule

PIV/NCE

Linezolid

Zyvox

Pharmacia Upjohn

600 mg

4/18/2000

anti-infective

Tablet

PIV

Lubiprostone

Amitiza

Sucampo

8 and 24 mcg

1/31/2006

anti-constipation

Soft Gel

PIV

Lurasidone HCl

Latuda

Sunovion Pharms Inc.

40 and 80 mg

10/28/2010

anti-psychotic

Tablets

PIV

Metolazone

Zaroxolyn

USB Inc.

2.5, 5 and 10 mg

Prior to 1982

antidiuretic/hypertensive

Tablet

PI

Metoprolol Succinate

Toprol-XL

AstraZeneca

25, 50, 100 and 200mg

1/10/1992

anti-hypertensive

Tablet ER

PI

Micafungin

Mycamine

Astellas

50 mg

3/16/2005

antibiotic

Injectable

PIV

Miconazole Nitrate

TBD

TBD

2%

TBD

anti-fungal

Semi-Solid

NDA

Milnacipran

Savella

Cypress

12.5, 25, 50 and 100 mg

1/14/2009

Serotonin and norepinephrine reuptake inhibitor

Tablet

PIV

Mometasone Furoate Monohydrate

Nasonex

Schering Plough

0.05mg Base

10/1/1997

corticosteroid

Spray Metered

PIV

Mycophenolate Mofetil HCl

Cellcept

Roche

500 mg

8/12/1998

anti-rejection

Injectable

PI

Naratriptan Hydrochloride

Amerge

GSK

1 and 2.5 mg Base

2/10/1998

anti-migraine

Tablet

PI

Nesiritide

Natrecor

Scios

1.5 mg/vial

8/10/2001

cardiac

Injectable

PI

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Dosage Form Filing Strategy

Nilotinib Hydrochloride Monohydrate

Tasigna

Novartis

150 and 200 mg

10/29/2007

anti-cancer

Capsule

PIV

Norepinephrine Bitartrate

Levophed

Hospira

1 mg Base/mL

Prior to 1982

anti-hypertensive

Injectable

PI

Olanzapine

Zyprexa

Lilly

2.5, 5 and 10 mg

9/30/1996

anti-psychotic

Tablet

PI

Olanzapine

Zyprexa Zydis

Lilly

2.5, 5 and 10 mg

8/6/2000

anti-psychotic

Oral Dis Tab

PI

Olmesartan Medoxomil

Benicar

Daiichi Sankyo

5, 20 and 40 mg

4/25/2002

Hypertension

Tablet

PIV

Olmesartan Medoxomil/HCTZ

Benicar HCT

Daiichi Sankyo

20mg/12.5mg, 40mg/12.5mg and 40mg/25 mg

6/5/2003

Hypertension

Tablet

PIV

Olmesartan Medoxomil/ Amlodipine Besylate

Azor

Daiichi Sankyo

092/26/2007

Hypertension

Tablet

PI

Olmesartan Medoxomil/ Amlodipine Besylate/HCTZ

Tribenzor

Daiichi Sankyo

7/31/2010

Hypertension

Tablet

PI

Paliperidone

Invega

Janssen Pharm

1.5, 3, 6, 9mg

12/9/2006

anti-psychotic

Tablet ER

PI

Palonosetron HCl

Aloxi

Helsinn Healthcare

0.075mg Base/1.5mL 0.25 mg Base/5mL

7/25/2003

anti-emetic

Injectable

PIV

Pemetrexed Disodium

Alimta

Lilly

100 and 500 mg

2/4/2004

anti-neoplastic

Injectable

PIV

Phytonadione

Vitamin K1

Hospira

10mg/mL and 1mg/0.4mL

Prior to 1982

blood coagulation modifier

Injectable

PI

Plerixafor

Mozobil

Genzyme

24mg; 1.2mL

12/15/2008

hematopoietic stem cell mobilizers

Solution; Injectable

PIV

Pomalidomide

Pomalyst

Celgene

1, 2, 3 and 4 mg

2/8/2013

immune modulator

Capsule

PIV

Posaconazole

Noxafil

Merck Sharp Dohme

100 mg

11/25/2013 03/13/2014

anti-fungal

Tablet DR Injectable

PIV

Pramipexole Dihydrochloride

Mirapex

Boehringer Ingelheim

.125, .25, .5, .75, 1, and 1.5mg

7/1/1997

anti-Parkinson

Tablet

PI

Raloxifene

Evista

Lilly

60 mg

12/9/1997

estrogen agonist/ antagonist

Tablet

PIV

20mg/EQ 10mg, 40mg/EQ 12.5mg 40mg/EQ 25mg 20mg/12.5mg/5mg 40mg/12.5mg/5mg 40mg/25mg/5mg 40mg/12.5mg/10mg 40mg/25mg/10 mg

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Risedronate Sodium

Actonel

Warner Chilcott

5, 30 and 35 mg

3/27/1997

Rivaroxaban

Xarelto

Janssen Pharms

10, 15 and 20 mg

7/1/2011

Romidepsin

Istodax

Celgene

10mg/vial

Sevoflurane

Ultane

Abbvie

Silver Sulfadiazine

Silvadene

Sitagliptan Phosphate

Januvia

Therapeutic Category

Dosage Form Filing Strategy Tablet

PIII

anti-coagulate

Tablet

PIV

10/5/2009

anti-neoplastic

Powder/IV

PIV

100%

6/7/1995

anesthetic

Liquid Inhalation

PIV

King Pharm

1%

Prior to 1982

anti-bacterial

Semi-Solid

PI

Merck Sharp Dohme

25, 50 and 100 mg

10/16/2006

anti-diabetic

Tablet

PIII

antibiotic

Semi-Solid

NDA

Sodium Fusidate

2%

rheumatoid arthritis

Sodium Nitroprusside

Nitropress

Hospira

25mg/mL

8/1/1988

anti-hypertensive

Injectable

PI

Sunitinib Malate

Sutent

CPPI CV

12.5, 25, 37.5 and 50 mg

1/26/2006

anti-cancer

Capsule

PIV

Telmisartan

Micardis

BI

20, 40, 80 mg

11/10/1998

Hypertension

Tablet

PIV

Telmisartan HCTZ

Micardis HCTZ

BI

40mg/12.5, 80mg/12.5, 80mg/25mg

11/17/2000

Hypertension

Tablet

PIV

Temazepam

Restoril

Mallinckrodt

7.5, 15, 22.5, and 30 mg

Prior to 1982

anti-anxiety

Capsule

PI

Temozolomide

Temodar

Merck Sharp Dohme

5, 20, 100, 140, 180 and 250 mg

8/11/1999

anti-neoplastic

Capsule

PI

Terbinafine

TBD

TBD

1%

TBD

anti-fungal

Semi-Solid

NDA

Tigecycline

Tygacil

PF Prism

50 mg

6/15/2005

anti-infective

Injectable

PIV

Tofacitinib Citrate

Xeljanz

PF Prism

EQ 5 mg Base

11/6/2012

anti-rheumatic

Tablet

505b2

Topiramate XR

Trokendi XR

Supernuts Pharma USA

25, 50, 100 and 200 mg

8/16/2013

anti-consultants

Capsule

PIV

Trientine Hydrochloride

Syprine

Aton

250 mg

11/8/1985

heavy metal chelator

Capsule

PI

Updated 1/20/2015

Product

Brand

Innovator

Strengths

Brand Approved

Therapeutic Category

Hoffmann LA Roche

240 mg

8/27/2011

anti-cancer

Tablet

PIV

Teva

25, 37.5, 50, 75, 100 mg

8/3/2006

Serotonin and norepinephrine reuptake inhibitor

Tablet

PI

Forest labs

10, 20 and 40 mg

1/21/2011

anti-psychotic

Tablets

PIV

Dosage Form Filing Strategy

Vemurafenib

Zelboraf

Venlafaxine HCl

Venlafaxine HCl

Vilazodone

Viibryd

Voriconazole

Vfend

Pfizer

200mg/5mL

12/19/2003

anti-psychotic

Injectable

PIII

Ziconotide Acetate

Prialt

Jazz Pharm

100mcg/1mL, 500mcg/5mL and 500 mcg/20mL

12/28/2004

channel antagonist (pain)

Injectable

PIV

Zolmitriptan

Zomig

IPR

2.5 and 5 mg

11/25/1997

anti-migraine

Tablets

PI

Updated 1/20/2015