Details for New Drug Application (NDA): 216414
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NDA 216414 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Ani Pharms, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Onesource Specialty, Ph Health, Piramal Critical, Xiromed, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty-eight suppliers. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.
The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
The generic ingredient in LEVOTHYROXINE SODIUM is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 216414
| Tradename: | LEVOTHYROXINE SODIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216414
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 216414 | ANDA | Aurobindo Pharma Limited | 59651-554 | 59651-554-90 | 90 TABLET in 1 BOTTLE (59651-554-90) |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 216414 | ANDA | Aurobindo Pharma Limited | 59651-554 | 59651-554-99 | 1000 TABLET in 1 BOTTLE (59651-554-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.137MG | ||||
| Approval Date: | Jul 16, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.15MG | ||||
| Approval Date: | Jul 16, 2024 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.175MG | ||||
| Approval Date: | Jul 16, 2024 | TE: | RLD: | No | |||||
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