Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074586
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| M-ZOLE 7 DUAL PACK | MICONAZOLE NITRATE | 2%,100MG | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/17/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074586.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/08/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |