Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084710
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OGEN | ESTROPIPATE | 1.5MG/GM | CREAM;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1977 | 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 |
|---|---|---|---|---|---|
| 11/03/2015 | SUPPL-22 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/01/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 04/02/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/02/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/03/1984 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |