Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085865
Company: WATSON LABS
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. |
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| 12/08/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 09/20/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1989 | SUPPL-21 | Bioequivalence |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/05/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/01/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |