Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020901
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METROLOTION | METRONIDAZOLE | 0.75% | LOTION;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/24/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20901ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20901.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/07/2015 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/11/2004 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20901slr002ltr.pdf | |
12/06/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/11/2004 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf | |
11/24/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf |
METROLOTION
LOTION;TOPICAL; 0.75%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROLOTION | METRONIDAZOLE | 0.75% | LOTION;TOPICAL | Prescription | Yes | AB | 020901 | GALDERMA LABS LP |
METRONIDAZOLE | METRONIDAZOLE | 0.75% | LOTION;TOPICAL | Prescription | No | AB | 077197 | FOUGERA PHARMS |