Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062438
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRISACTIN ULTRA | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | 165MG | TABLET;ORAL | Discontinued | None | No | No |
| GRISACTIN ULTRA | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | 330MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/17/1983 | 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 |
|---|---|---|---|---|---|
| 01/31/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1991 | SUPPL-10 | Bioequivalence |
Label is not available on this site. |
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| 03/27/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |