Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017048
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEPTAVLON | PENTAGASTRIN | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/26/1974 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 11/14/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/21/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/28/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/12/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/16/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/16/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/27/1985 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/27/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/19/1981 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/15/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |