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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086030
Company: WATSON PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription AO No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/1981 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2016 SUPPL-50 Labeling-Package Insert

Label is not available on this site.
07/22/2015 SUPPL-49 Labeling-Package Insert

Label is not available on this site.
05/11/2015 SUPPL-48 Labeling-Package Insert

Label is not available on this site.
06/19/2014 SUPPL-46 Labeling-Package Insert

Label is not available on this site.
06/16/2004 SUPPL-24 Labeling

Label is not available on this site.
02/19/1999 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
02/02/1999 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/28/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
12/04/1996 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/20/1993 SUPPL-18 Labeling

Label is not available on this site.
07/16/1991 SUPPL-17 Labeling

Label is not available on this site.
04/07/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
02/16/1990 SUPPL-15 Labeling

Label is not available on this site.
04/07/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
08/02/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
08/02/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
06/09/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
05/29/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
05/29/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/09/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
11/15/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION; 200MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription Yes AO 085635 PFIZER
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 207742 AM REGENT
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 210362 CIPLA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 211817 EUGIA PHARMA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 090387 HIKMA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 091244 HIKMA FARMACEUTICA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040530 PADAGIS US
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040615 SANDOZ
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 201720 SUN PHARM INDS LTD
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 086030 WATSON PHARMS INC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 206368 WILSHIRE PHARMS INC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 215351 XIROMED
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