Skip to contentApplication 021623
- Type
- NDA
- Sponsor
- GALEN SPECIALTY
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SYNERA | LIDOCAINE; TETRACAINE | PATCH;TOPICAL | 70MG;70MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10885-002 | Synera | lidocaine and tetracaine | Galen US Incorporated | NDA | Current |
| 10885-002 | Synera | lidocaine and tetracaine | Galen US Incorporated | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65638 | SUPPL | 2020-12-21 |
| 65620 | SUPPL | 2020-12-17 |
| 56396 | SUPPL | 2018-11-09 |
| 56273 | SUPPL | 2018-11-05 |
| 28258 | SUPPL | 2014-03-13 |
| 28257 | SUPPL | 2014-03-13 |
| 37345 | SUPPL | 2014-03-11 |
| 15883 | SUPPL | 2014-03-11 |
| 42237 | ORIG | 2008-03-14 |
| 28256 | ORIG | 2005-06-24 |
| 15882 | ORIG | 2005-06-24 |