Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021789
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METROGEL | METRONIDAZOLE | 1% | GEL;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 |
---|---|---|---|---|---|---|---|
06/30/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021789s000_MetrogelTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2023 | SUPPL-13 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021789Orig1s013ltr.pdf | |
03/16/2022 | SUPPL-10 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021789 Orig1s009, s010ltr.pdf | |
03/16/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021789 Orig1s009, s010ltr.pdf | |
01/12/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/04/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/19/2011 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021789s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021789Orig1s004.pdf | |
03/05/2010 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021789s003ltr.pdf | |
08/29/2006 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/14/2005 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/22/2023 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf | |
11/22/2023 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf | |
03/16/2022 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf | |
03/16/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf | |
10/19/2011 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf | |
03/05/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf | |
11/14/2005 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf | |
06/30/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf |
METROGEL
GEL;TOPICAL; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METROGEL | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | Yes | AB | 021789 | GALDERMA LABS LP |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 212646 | ALEMBIC |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 216692 | COSETTE |
METRONIDAZOLE | METRONIDAZOLE | 1% | GEL;TOPICAL | Prescription | No | AB | 204651 | TARO |