Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071539
Company: HERITAGE PHARMA
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORETHIN 1/50M-21 | MESTRANOL; NORETHINDRONE | 0.05MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/12/1988 | 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 |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/11/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 12/23/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/11/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 09/09/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/19/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |