Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020525
Company: BAYER HEALTHCARE LLC
Company: BAYER HEALTHCARE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GYNE-LOTRIMIN 3 | CLOTRIMAZOLE | 200MG | TABLET;VAGINAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1996 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/01/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1997 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |