Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019897
Company: POPULATION COUNCIL
Company: POPULATION COUNCIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORPLANT | LEVONORGESTREL | 36MG/IMPLANT | IMPLANT;IMPLANTATION | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/25/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/15/1997 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 10/07/1997 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/15/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/16/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/31/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/31/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1993 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |