Application 020612
- Type
- NDA
- Sponsor
- TEIKOKU PHARMA USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LIDODERM | LIDOCAINE | PATCH;TOPICAL | 5% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0603-1880 | Lidocaine | lidocaine | Par Pharmaceutical | NDA AUTHORIZED GENERIC | Current |
| 49999-419 | LIDODERM | lidocaine | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 50090-1359 | Lidocaine | lidocaine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50436-1331 | LIDODERM | lidocaine | Unit Dose Services | NDA | Current |
| 55154-7228 | Lidocaine | lidocaine | Cardinal Health | NDA AUTHORIZED GENERIC | Current |
| 55154-7228 | Lidocaine | lidocaine | Cardinal Health | NDA AUTHORIZED GENERIC | Current |
| 55154-7228 | Lidocaine | lidocaine | Cardinal Health 107, LLC | NDA AUTHORIZED GENERIC | Current |
| 55700-142 | Lidocaine | lidocaine | Lake Erie Medical DBA Qua | NDA AUTHORIZED | Current |
| 55700-142 | Lidocaine | lidocaine | Lake Erie Medical DBA Quality Care Products LLC | NDA AUTHORIZED GENERIC | Current |
| 60760-880 | Lidocaine | lidocaine | St. Mary's Medical Park Pharmacy | NDA AUTHORIZED GENERIC | Current |
| 61919-588 | LIDOCAINE | LIDOCAINE | DIRECT RX | NDA AUTHORIZED GENERIC | Current |
| 61959-001 | LIDODERM | Lidocaine Patch 5% | TPU Pharma, Inc. | NDA | Current |
| 63481-687 | LIDODERM | lidocaine | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-687 | LIDODERM | lidocaine | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-687 | LIDODERM | lidocaine | Endo Pharmaceuticals, Inc. | NDA | Current |
| 68071-2460 | Lidocaine | lidocaine | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-7159 | Lidocaine | lidocaine | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-7159 | Lidocaine | lidocaine | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-7159 | Lidocaine | lidocaine | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-7159 | Lidocaine | lidocaine | Preferred Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 71335-1934 | Lidocaine | lidocaine | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 76519-1044 | LIDOCAINE | LIDOCAINE | H.J. Harkins Company, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56357 | SUPPL | 2018-11-08 |
| 56265 | SUPPL | 2018-11-05 |
| 12848 | SUPPL | 2015-01-08 |
| 2879 | SUPPL | 2015-01-08 |
| 34958 | SUPPL | 2010-04-19 |
| 2878 | SUPPL | 2010-04-19 |
| 41480 | SUPPL | 2006-10-26 |
| 20767 | SUPPL | 2006-10-26 |
| 12847 | SUPPL | 2006-05-01 |
| 2877 | SUPPL | 2006-05-01 |
| 34957 | SUPPL | 2005-05-17 |
| 2876 | SUPPL | 2005-05-17 |
| 20766 | ORIG | 1999-06-17 |
| 34956 | ORIG | 1999-03-19 |
| 2875 | ORIG | 1999-03-19 |