Androgel 1.62%

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ACTIVE PHARMA INGREDIENTS

96 API Suppliers, 23 USDMF, 10 CEP/COS, 14 EU WC, 46 NDC API, 35 Listed Suppliers, $ API Reference Price

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93 Drugs in Development

93 Drugs in Development

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 60 FDA Orange Book, 118 Europe, 7 Canada, 8 Australia, 8 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION, GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION, GEL;TRANSDERMAL - 25MG/2.5GM PACKET, GEL;TRANSDERMAL - 50MG/5GM PACKET, GEL;TRANSDERMAL - 50MG/5GM PACKET, TABLET, EXTENDED RELEASE;BUCCAL - 30MG, GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION), GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET), SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 SPI Pharma, 4 DKSH, 6 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 23 BASF, 1 BioSpectra, 2 CD Formulation, 2 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 7 Lubrizol Life Science Health, 14 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

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56 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 38 Topical, 30 Thickeners and Stabilizers, 28 Direct Compression, 26 Granulation, 24 Controlled & Modified Release, 18 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 15 Parenteral, 15 Film Formers & Plasticizers, 15 Solubilizers, 13 Co-Processed Excipients, 8 Chewable & Orodispersible Aids, 8 Taste Masking, 7 Emulsifying Agents, 6 API Stability Enhancers, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

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2 Analytical Methods

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USFDA APPLICATION NUMBER - 21454 / DOSAGE - GEL;TRANSDERMAL - 50MG/5GM PACKET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TESTOSTERONE(UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	50mg in 5

Inactive Ingredients

Ingredient Name	A-S Medication Solutions LLC	AbbVie Inc.	Bryant Ranch Prepack	Encube Ethicals Private Limited
alcohol(3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E)
carbomer homopolymer type C(4Q93RCW27E)
isopropyl myristate(0RE8K4LNJS)
sodium hydroxide(55X04QC32I)
water(059QF0KO0R)

Drug Product Composition: Androgel 1.62%

Androgel 1.62%

Androgel 1.62%

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

96 API Suppliers

23 USDMF

10 CEP/COS

14 EU WC

46 NDC API

35 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

93 Drugs in Development

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers

60 FDA Orange Book

118 Europe

7 Canada

8 Australia

8 South Africa

15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION

GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION

GEL;TRANSDERMAL - 25MG/2.5GM PACKET

GEL;TRANSDERMAL - 50MG/5GM PACKET

GEL;TRANSDERMAL - 50MG/5GM PACKET

TABLET, EXTENDED RELEASE;BUCCAL - 30MG

GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION)

GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET)

SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 SPI Pharma

4 DKSH

6 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

6 Kirsch Pharma

1 ACG Worldwide

7 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

23 BASF

1 BioSpectra

2 CD Formulation

2 Clariant

15 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

7 Lubrizol Life Science Health

14 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons