Details for New Drug Application (NDA): 209713
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NDA 209713 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Maia Pharms Inc, Piramal Critical, 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 nineteen NDAs. It is available from thirty-six 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-one 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-one suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 209713
| Tradename: | LEVOTHYROXINE SODIUM |
| Applicant: | Lupin |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209713
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713 | ANDA | Major Pharmaceuticals | 0904-6949 | 0904-6949-61 | 100 BLISTER PACK in 1 CARTON (0904-6949-61) / 1 TABLET in 1 BLISTER PACK |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713 | ANDA | Major Pharmaceuticals | 0904-6950 | 0904-6950-61 | 100 BLISTER PACK in 1 CARTON (0904-6950-61) / 1 TABLET in 1 BLISTER PACK |
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: | Jan 18, 2019 | TE: | AB1,AB2,AB3 | 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: | Jan 18, 2019 | TE: | AB1,AB2,AB3 | 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: | Jan 18, 2019 | TE: | AB1,AB2,AB3 | RLD: | No | ||||
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