Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019737
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METROGEL | METRONIDAZOLE | 0.75% | GEL;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/22/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/04/2002 | SUPPL-7 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19737s007ltr.pdf |
| 08/21/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/24/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1989 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/19/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |