Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085239
Company: DR REDDYS
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/28/1989 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 05/13/1998 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/1996 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 05/01/1991 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1989 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 12/28/1988 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1988 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1988 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1986 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |