Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040212
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GYNODIOL | ESTRADIOL | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| GYNODIOL | ESTRADIOL | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| GYNODIOL | ESTRADIOL | 1.5MG | TABLET;ORAL | Discontinued | None | No | No |
| GYNODIOL | ESTRADIOL | 2MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1997 | 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 |
|---|---|---|---|---|---|
| 12/12/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 06/19/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/10/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |