Documents
Application Sponsors
| NDA 021789 | GALDERMA LABS LP | |
Marketing Status
Application Products
| 001 | GEL;TOPICAL | 1% | 1 | METROGEL | METRONIDAZOLE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2006-08-29 | N/A |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-03-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-10-19 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2014-09-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-03-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21789
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)