Details for New Drug Application (NDA): 212399
NDA 212399 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, Alembic, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-two NDAs. It is available from thirty-eight suppliers. There are eight 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 is one drug master file entry for this compound. Fifty 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 is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 212399
| Tradename: | LEVOTHYROXINE SODIUM |
| Applicant: | Accord Hlthcare |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212399
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 212399 | ANDA | Accord Healthcare Inc. | 16729-447 | 16729-447-15 | 90 TABLET in 1 BOTTLE (16729-447-15) |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 212399 | ANDA | Accord Healthcare Inc. | 16729-447 | 16729-447-17 | 1000 TABLET in 1 BOTTLE (16729-447-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | ||||
| Approval Date: | Oct 19, 2020 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
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