Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESTRONE | ESTRONE | 5MG/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 |
---|---|---|---|---|---|---|---|
02/21/1979 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085239_estrone_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/03/2017 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
02/19/1999 | SUPPL-59 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
02/02/1999 | SUPPL-58 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/13/1998 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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08/20/1996 | SUPPL-56 | Labeling |
Label is not available on this site. |
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05/01/1991 | SUPPL-55 | Labeling |
Label is not available on this site. |
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03/28/1991 | SUPPL-54 | Labeling |
Label is not available on this site. |
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02/22/1991 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1991 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1989 | SUPPL-51 | Labeling |
Label is not available on this site. |
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12/28/1988 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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12/28/1988 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/1988 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1986 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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08/24/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |