Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062178
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRISACTIN ULTRA | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | 125MG | TABLET;ORAL | Discontinued | None | No | No |
| GRISACTIN ULTRA | GRISEOFULVIN, ULTRAMICROCRYSTALLINE | 250MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/13/1980 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/062178Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1991 | SUPPL-14 | Bioequivalence |
Label is not available on this site. |
||
| 09/03/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |