Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017352
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FASTIN | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 08/14/1973 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/16/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/16/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 10/10/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/24/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1984 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/31/1981 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/31/1981 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/17/1981 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/29/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 10/11/1978 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/02/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/22/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/03/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/10/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |