Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083547
Company: DR REDDYS
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 |
|---|---|---|---|---|---|
| 05/24/1990 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-84 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-82 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-81 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 04/25/1995 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1991 | SUPPL-78 | Labeling |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 12/18/1990 | SUPPL-76 | Labeling |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1986 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1984 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1982 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |