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TESTOSTERONE

ANDA

TESTOSTERONE | A205781 | PADAGIS ISRAEL PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ANDROGEL(TE code: AB2)

API Supply Chain15 active DMFs13 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVTESTOSTERONE

DMF 118261996

BAYER AGTESTOSTERONE

DMF 150772000

BAYER AGTESTOSTERONE UNDECANOATE 750 MG I.M.

DMF 168092003

DR REDDYS LABORATORIES LTDTESTOSTERONE

DMF 236712010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE UNDECANOATE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 239342010

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE PROPIONATE, USP (MICRONIZED)

DMF 255352011

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE ENANTHATE, USP

DMF 261662012

SUN PHARMACEUTICAL INDUSTRIES LTDTESTOSTERONE USP

DMF 274472013

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE USP (MICRONIZED)

DMF 298692015

LUPIN LTDTESTOSTERONE USP

DMF 303772016

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE

DMF 307412016

CURIA SPAIN SAUTESTOSTERONE MICRONIZED

DMF 328172018

HUBEI GOTO BIOTECHNOLOGY CO LTDTESTOSTERONE

DMF 331182018

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE

DMF 370742022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE TRIDECANOATE

DMF 378902023

F.X. GASSNER, COLORADO STATE UNIVERSITYInactiveTESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY?

DMF 2741940

DIOSYNTH BVInactiveTESTOSTERONE

DMF 39741980

ROUSSELL UCLAFInactiveTESTOSTERONE (DIOSYNTH BV)

DMF 45121982

SCHERING AGInactiveTESTOSTERONE

DMF 46951982

MEDISORB TECHNOLOGIES INTERNATIONAL LTD PARTNERSHIPInactiveTESTOSTERONE INJECTABLE MICROSPHERES

DMF 75021988

SIGMA F AND D DIV LTDInactiveTESTOSTERONE

DMF 99311992

ARDANA BIOSCIENCE LTDInactiveTESTOSTERONE CREAM 1% (ARD-0403)

DMF 193492006

CIPLA LTDInactiveTESTOSTERONE USP

DMF 215462008

BIOVET JOINT STOCK COInactiveTESTOSTERONE

DMF 231572009

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAInactiveTESTOSTERONE L-2

DMF 243102010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE PROPIONATE NON-STERILE BULK DRUG SUBSTANCE

DMF 256062011

INDO PHYTO CHEMICALS PRIVATE LTDInactiveTESTOSTERONE USP

DMF 264302012

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE ENANTHATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 274312013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 14, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 1.62% (20.25MG/1.25GM PACKET)

AB2

0 patents0 exclusivities▴

GEL;TRANSDERMAL | Approved: Jul 12, 2017

No patent or exclusivity listings for this strength.

#002 — 1.62% (40.5MG/2.5GM PACKET)

AB2

0 patents0 exclusivities▾

GEL;TRANSDERMAL | Approved: Jul 12, 2017