Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRADIOL VALERATE | ESTRADIOL VALERATE | 20MG/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 |
---|---|---|---|---|---|---|---|
02/28/1979 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/083547.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/19/1999 | SUPPL-84 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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09/25/1998 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1999 | SUPPL-82 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/04/1996 | SUPPL-81 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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08/16/1996 | SUPPL-80 | Labeling |
Label is not available on this site. |
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04/25/1995 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1991 | SUPPL-78 | Labeling |
Label is not available on this site. |
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04/26/1991 | SUPPL-77 | Labeling |
Label is not available on this site. |
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12/18/1990 | SUPPL-76 | Labeling |
Label is not available on this site. |
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05/24/1990 | SUPPL-75 | Labeling |
Label is not available on this site. |
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10/21/1988 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1988 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1986 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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09/05/1984 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1982 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |