Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072692
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORTREL 0.5/35-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-21 | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1992 | 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 |
|---|---|---|---|---|---|
| 12/04/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/22/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/21/1999 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/07/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |