Application 202231
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 100MCG/VIAL | Yes | Yes |
| 002 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 200MCG/VIAL | Yes | Yes |
| 003 | LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | POWDER;INTRAVENOUS | 500MCG/VIAL | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42023-201 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-201 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-201 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-202 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-202 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-202 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-203 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-203 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 42023-203 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Par Pharmaceutical Inc. | NDA | Current |
| 63323-647 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-647 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-648 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-648 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-648 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-648 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-649 | Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | Fresenius Kabi USA, LLC | NDA | Current |
| 66794-647 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66794-647 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66794-648 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66794-648 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66794-649 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66794-649 | Levothyroxine Sodium | Levothyroxine Sodium | Piramal Critical Care, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9993 | SUPPL | 2012-12-26 |
| 19298 | SUPPL | 2012-12-21 |
| 44848 | ORIG | 2012-03-09 |
| 22879 | ORIG | 2012-03-09 |
| 32210 | ORIG | 2011-07-05 |
| 19297 | ORIG | 2011-06-28 |