Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085603
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE 2MG/ML;50MG/ML INJECTABLE;INJECTION Discontinued None 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
03/13/1986 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
02/19/1999 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/15/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/15/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/31/1996 SUPPL-13 Labeling

Label is not available on this site.

04/17/1991 SUPPL-12 Labeling

Label is not available on this site.

03/27/1991 SUPPL-11 Labeling

Label is not available on this site.

07/24/1989 SUPPL-10 Labeling

Label is not available on this site.

12/21/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/14/1988 SUPPL-5 Labeling

Label is not available on this site.

07/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/17/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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