Application 040837
- Type
- ANDA
- Sponsor
- WATSON LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | JELLY;TOPICAL | 2% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-3012 | Lidocaine | Lidocaine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 53217-222 | Lidocaine | Lidocaine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-223 | Lidocaine | Lidocaine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42638 | ORIG | 2013-10-23 |