Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084950
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MENEST | ESTROGENS, ESTERIFIED | 1.25MG | TABLET;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1977 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2019 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/10/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |