Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085865
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE 4MG/ML;90MG/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
05/07/1981 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/85865ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/1999 SUPPL-35 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-34 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/08/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/04/1996 SUPPL-32 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/20/1996 SUPPL-31 Labeling

Label is not available on this site.

04/17/1991 SUPPL-30 Labeling

Label is not available on this site.

07/24/1990 SUPPL-29 Labeling

Label is not available on this site.

09/20/1991 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/20/1991 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/20/1991 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/18/1989 SUPPL-21 Bioequivalence

Label is not available on this site.

04/30/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/05/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/01/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/04/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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