Testosterone Injectable Solution

Brand(s)
Aveed, Delatestryl, Depo-testosterone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Endo Pharmaceuticals Solutions Inc. (2015-05-20)
Oldest Current Product
1953-12-24
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\TESTOSTERONE
FDAOB
INJECTION\INJECTION\TESTOSTERONE CYPIONATE\rdfq
INJECTION\INJECTION\TESTOSTERONE ENANTHATE\rdfq
INTRAMUSCULAR\INJECTION\TESTOSTERONE UNDECANOATE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\TESTOSTERONE CYPIONATE
INTRAMUSCULAR\INJECTION, SOLUTION\TESTOSTERONE ENANTHATE
INTRAMUSCULAR\INJECTION\TESTOSTERONE CYPIONATE
INTRAMUSCULAR\INJECTION\TESTOSTERONE UNDECANOATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\TESTOSTERONE
INTRAMUSCULAR\INJECTION\TESTOSTERONE

product(s) by strength(s)

testosterone cypionate 100 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090085Depo-testosteroneANDAPharmacia And Upjohn Company2014-07-01TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA085635735b5bf3-4464-412c-a072-1bd02f2e5380
2000090347Depo-testosteroneANDAPharmacia And Upjohn Company1979-07-25TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA085635cfbb53d4-b868-4a28-8436-f9112eb01c39
3627560017ANDASun Pharmaceutical Industries Limited2013-06-17TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA2017203653a602-4551-4e6c-84a7-31861f5dc482

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1500900746Depo-testosteroneANDAA-S Medication Solutions Llc1979-07-25TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION000090347ANDA085635cf8407e9-102b-4735-9b74-9e1e441aef3f
2545695301Depo-testosteroneANDAA-S Medication Solutions Llc1979-07-25TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION000090347ANDA085635b32c605c-79a1-4286-a399-b107974c8ee7
3548683669ANDAPhysicians Total Care, Inc.2006-08-10TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION007813073ANDA040615a34023dc-fc54-4f66-bab0-9596502c23a3

testosterone cypionate 200 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000090086Depo-testosteroneANDAPharmacia And Upjohn Company2014-07-01TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA085635735b5bf3-4464-412c-a072-1bd02f2e5380
2000090417Depo-testosteroneANDAPharmacia And Upjohn Company1979-07-25TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA085635cfbb53d4-b868-4a28-8436-f9112eb01c39
3000090520Depo-testosteroneANDAPharmacia And Upjohn Company2014-03-31TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA085635fe808a56-7542-4d23-97b4-d98a3ef63016
4001439726ANDAWest-Ward Pharmaceutical Corp2012-05-01TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTIONANDA091244f60c5520-b336-44a2-95d5-f274939fa595
5005740820ANDAPaddock Laboratories, Llc2007-12-21TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA0405304195516a-c8e6-457c-b805-43c9a3ca8b77
6005740827ANDAPaddock Laboratories, Llc2014-05-01TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA091244e3e2da65-4b2a-4210-a6ff-cc08c8567381
7005913223ANDAWatson Laboratories, Inc.2011-05-042017-05-31TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA086030a38f852b-e260-42c9-a37a-e07c97a01c42
8005914128ANDAWatson Laboratories, Inc.2015-03-05TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTIONANDA091244d7b57b68-dca6-4df2-b3f2-7017d7b69f17
9627560015ANDASun Pharmaceutical Industries Limited2013-06-17TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA2017203653a602-4551-4e6c-84a7-31861f5dc482
10627560016ANDASun Pharmaceutical Industries Limited2013-06-17TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTIONANDA2017203653a602-4551-4e6c-84a7-31861f5dc482

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1500900330ANDAA-S Medication Solutions Llc2012-05-01TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION001439726ANDA091244d77c3f41-fdc5-4e51-8714-c82ddb43dc85
2500900331ANDAA-S Medication Solutions Llc2011-05-04TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION005913223ANDA086030786cfd08-40a2-420a-bb29-230db15816bc
3545691411Depo-testosteroneANDAA-S Medication Solutions Llc1979-07-25TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION000090417ANDA0856358bdbb5b1-c294-422f-8bfd-975caab39939
4545692131ANDAA-S Medication Solutions Llc2011-05-04TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION005913223ANDA08603059fe1585-2558-488e-8c53-8109fa59073d
5548680216Depo-testosteroneANDAPhysicians Total Care, Inc.1994-07-12TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION000090417ANDA085635837570cb-8a33-4129-ad41-bead378d9987
6548683618ANDAPhysicians Total Care, Inc.2007-08-10TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION005740820ANDA040530108facca-c6d2-48fa-ba48-667c9498c61b
7550452092ANDADispensing Solutions, Inc.2011-05-04TESTOSTERONE CYPIONATEINTRAMUSCULARINJECTION, SOLUTION005913223ANDA086030ad391b4b-232e-48cf-a226-d8fd750a7c36

testosterone enanthate 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1679790501DelatestrylNDAEndo Pharmaceuticals Solutions Inc.1953-12-24TESTOSTERONE ENANTHATEINTRAMUSCULARINJECTION, SOLUTIONNDA00916567e2cc36-a379-11dc-8314-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439750ANDAWest-Ward Pharmaceutical Corp2012-09-18TESTOSTERONE ENANTHATEINTRAMUSCULARINJECTION, SOLUTIONANDA091120e89d6458-428c-4256-97a3-f1fa851293c1
2005913221ANDAWatson Laboratories, Inc.2011-05-04TESTOSTERONE ENANTHATEINTRAMUSCULARINJECTION, SOLUTIONANDA085598a0af5e80-8d01-4aa9-9f33-926735fdd38a

testosterone undecanoate 250 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1679790511AveedNDAEndo Pharmaceuticals Solutions Inc.2014-03-05TESTOSTERONE UNDECANOATEINTRAMUSCULARINJECTIONNDA022219f80f025b-17d8-40af-8739-20ce07902045

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1ANDA040530TESTOSTERONE CYPIONATEPADDOCK LABORATORIES LLC2005-01-31ANDA040530_001
2ANDA040575TESTOSTERONE ENANTHATEPADDOCK LABORATORIES LLC2006-06-14ANDA040575_001
3ANDA040615TESTOSTERONE CYPIONATESANDOZ CANADA INC2006-08-10ANDA040615_001, ANDA040615_002
4ANDA040647TESTOSTERONE ENANTHATEMYLAN INSTITUTIONAL LLC2009-10-05ANDA040647_001
5ANDA040652TESTOSTERONE CYPIONATEMYLAN INSTITUTIONAL LLC2006-12-11ANDA040652_001
6ANDA083667TESTOSTERONE ENANTHATETrueWATSON LABORATORIES INCANDA083667_001, ANDA083667_002
7ANDA084401TESTOSTERONE CYPIONATETrueWATSON LABORATORIES INCANDA084401_001, ANDA084401_002
8ANDA085598TESTOSTERONE ENANTHATEWATSON LABORATORIES INCANDA085598_001
9ANDA085599TESTOSTERONE ENANTHATETrueWATSON LABORATORIES INCANDA085599_001
10ANDA085635DEPO-TESTOSTERONEPHARMACIA AND UPJOHN COANDA085635_001, ANDA085635_002, ANDA085635_003
11ANDA086029TESTOSTERONE CYPIONATETrueWATSON LABORATORIES INCANDA086029_001
12ANDA086030TESTOSTERONE CYPIONATEWATSON LABORATORIES INCANDA086030_001
13ANDA090387TESTOSTERONE CYPIONATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2010-07-15ANDA090387_001, ANDA090387_002
14ANDA091120TESTOSTERONE ENANTHATEHIKMA FARMACEUTICA PORTUGAL SA2012-09-18ANDA091120_001
15ANDA091244TESTOSTERONE CYPIONATEHIKMA FARMACEUTICA (PORTUGAL) SA2012-05-01ANDA091244_001
16ANDA201720TESTOSTERONE CYPIONATESUN PHARMACEUTICAL INDUSTRIES LTD2013-06-03ANDA201720_001, ANDA201720_002
17NDA009165DELATESTRYLENDO PHARMACEUTICALS INCNDA009165_001, NDA009165_003
18NDA022219AVEEDENDO PHARMACEUTICALS INC2014-03-05p7718640, SUBSTANCE
p8338395, TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
NEW PRODUCT [2017-03-05]NDA022219_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040530_001RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2005-01-31TESTOSTERONE CYPIONATE
2ANDA040575_001RXTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseAO2006-06-14TESTOSTERONE ENANTHATE
3ANDA040615_001RXTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONFalseAO2006-08-10TESTOSTERONE CYPIONATE
4ANDA040615_002RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2006-08-10TESTOSTERONE CYPIONATE
5ANDA040647_001RXTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseAO2009-10-05TESTOSTERONE ENANTHATE
6ANDA040652_001RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2006-12-11TESTOSTERONE CYPIONATE
7ANDA083667_001discontinuedTESTOSTERONE ENANTHATE (100MG/ML)INJECTIONFalseTESTOSTERONE ENANTHATE
8ANDA083667_002discontinuedTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseTESTOSTERONE ENANTHATE
9ANDA084401_001discontinuedTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONFalseTESTOSTERONE CYPIONATE
10ANDA084401_002discontinuedTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseTESTOSTERONE CYPIONATE
11ANDA085598_001RXTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseAOTESTOSTERONE ENANTHATE
12ANDA085599_001discontinuedTESTOSTERONE ENANTHATE (100MG/ML)INJECTIONFalseTESTOSTERONE ENANTHATE
13ANDA085635_001discontinuedTESTOSTERONE CYPIONATE (50MG/ML)INJECTIONFalseDEPO-TESTOSTERONE
14ANDA085635_002RXTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONTrueAODEPO-TESTOSTERONE
15ANDA085635_003RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONTrueAODEPO-TESTOSTERONE
16ANDA086029_001discontinuedTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONFalseTESTOSTERONE CYPIONATE
17ANDA086030_001RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAOTESTOSTERONE CYPIONATE
18ANDA090387_001RXTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONFalseAO2010-07-15TESTOSTERONE CYPIONATE
19ANDA090387_002RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2010-07-15TESTOSTERONE CYPIONATE
20ANDA091120_001RXTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseAO2012-09-18TESTOSTERONE ENANTHATE
21ANDA091244_001RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2012-05-01TESTOSTERONE CYPIONATE
22ANDA201720_001RXTESTOSTERONE CYPIONATE (100MG/ML)INJECTIONFalseAO2013-06-03TESTOSTERONE CYPIONATE
23ANDA201720_002RXTESTOSTERONE CYPIONATE (200MG/ML)INJECTIONFalseAO2013-06-03TESTOSTERONE CYPIONATE
24NDA009165_001discontinuedTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONFalseDELATESTRYL
25NDA009165_003RXTESTOSTERONE ENANTHATE (200MG/ML)INJECTIONTrueAODELATESTRYL
26NDA022219_001RXTESTOSTERONE UNDECANOATE (750MG/3ML)INTRAMUSCULARINJECTIONTrue2014-03-05AVEED

patent(s)

#idexpiration dateapplication(s)
1p7718640 (view patent)2027-03-14NDA022219
2p8338395 (view patent)2026-02-27NDA022219

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1108facca-c6d2-48fa-ba48-667c9498c61b (view SPL)Testosterone Cypionate Injection, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-032548683618
23653a602-4551-4e6c-84a7-31861f5dc482 (view SPL)TestosteroneCypionate Injection C-IIIprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-08-0512627560015, 627560016, 627560017
34195516a-c8e6-457c-b805-43c9a3ca8b77 (view SPL)Testosterone Cypionate Injection, USP CIII Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-07-2213005740820
459fe1585-2558-488e-8c53-8109fa59073d (view SPL)TESTOSTERONE CYPIONATE INJECTION USP FOR INTRAMUSCULAR USE ONLY C-III Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-051545692131
567e2cc36-a379-11dc-8314-0800200c9a66 (view SPL)DelatestrylprescriptionHuman PrescriptionEndo Pharmaceuticals Solutions Inc.MANUFACTURE2015-05-205679790501
6735b5bf3-4464-412c-a072-1bd02f2e5380 (view SPL)Depo-Testosterone testosterone cypionate injection, USP CIIIprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-065000090085, 000090086
7786cfd08-40a2-420a-bb29-230db15816bc (view SPL)TESTOSTERONE CYPIONATE INJECTION USP CIII FOR INTRAMUSCULAR USE ONLY Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-151500900331
8837570cb-8a33-4129-ad41-bead378d9987 (view SPL)Depo-Testosteronetestosterone cypionate injection, USPCIIIprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-02-261548680216
98bdbb5b1-c294-422f-8bfd-975caab39939 (view SPL)Depo-Testosteronetestosterone cypionate injection, USPCIIIprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-05-011545691411
10a0af5e80-8d01-4aa9-9f33-926735fdd38a (view SPL)TESTOSTERONE ENANTHATE INJECTION USP FOR INTRAMUSCULAR USE ONLY C-III Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-04-203005913221
11a34023dc-fc54-4f66-bab0-9596502c23a3 (view SPL)Testosterone Cypionate Injection, USP100 mg/mL and 200 mg/mLprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-021548683669
12a38f852b-e260-42c9-a37a-e07c97a01c42 (view SPL)TESTOSTERONE CYPIONATE INJECTION, USP CIII (1 mL) Rx OnlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-06-1516005913223
13ad391b4b-232e-48cf-a226-d8fd750a7c36 (view SPL)TESTOSTERONE CYPIONATE INJECTION USP FOR INTRAMUSCULAR USE ONLY C-III Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-10-023550452092
14b32c605c-79a1-4286-a399-b107974c8ee7 (view SPL)Depo-Testosteronetestosterone cypionate injection, USPCIIIprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-10-121545695301
15cf8407e9-102b-4735-9b74-9e1e441aef3f (view SPL)Depo-Testosteronetestosterone cypionate injection, USPCIIIprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-151500900746
16cfbb53d4-b868-4a28-8436-f9112eb01c39 (view SPL)Depo-Testosteronetestosterone cypionate injection, USPCIIIprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-1212000090347, 000090417
17d77c3f41-fdc5-4e51-8714-c82ddb43dc85 (view SPL)Testosterone Cypionate Injection, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2014-12-151500900330
18d7b57b68-dca6-4df2-b3f2-7017d7b69f17 (view SPL)TESTOSTERONE CYPIONATE INJECTION, USP Rx OnlyprescriptionHuman PrescriptionWatson Laboratories, Inc.2015-06-016005914128
19e3e2da65-4b2a-4210-a6ff-cc08c8567381 (view SPL)Testosterone Cypionate Injection, USP CIII Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-07-311005740827
20e89d6458-428c-4256-97a3-f1fa851293c1 (view SPL)TESTOSTERONE ENANTHATE INJECTION, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-11-186001439750
21f60c5520-b336-44a2-95d5-f274939fa595 (view SPL)Testosterone Cypionate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2015-11-2312001439726
22f80f025b-17d8-40af-8739-20ce07902045 (view SPL)These highlights do not include all the information needed to use AVEED safely and effectively. See full prescribing information for AVEED. AVEED (testosterone undecanoate) injection, for intramuscular use CIIIInitial U.S. Approval: 1953prescriptionHuman PrescriptionEndo Pharmaceuticals Solutions Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-05-2020679790511
23fe808a56-7542-4d23-97b4-d98a3ef63016 (view SPL)Depo-Testosterone testosterone cypionate injection, USP CIIIprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-08-066000090520

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII