Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060212
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRISACTIN | GRISEOFULVIN, MICROCRYSTALLINE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1972 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/060212Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/03/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |