Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073507
Company: P AND L
Company: P AND L
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;VAGINAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1993 | 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 |
|---|---|---|---|---|---|
| 04/22/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/20/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/21/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/08/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
MICONAZOLE NITRATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUPPOSITORY;VAGINAL; 100MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;VAGINAL | Over-the-counter | No | 073507 | P AND L |
| MONISTAT 7 | MICONAZOLE NITRATE | 100MG | SUPPOSITORY;VAGINAL | Over-the-counter | Yes | 018520 | MEDTECH PRODUCTS |