Details for New Drug Application (NDA): 206163
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NDA 206163 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in eighteen NDAs. It is available from thirty-two 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. Forty-eight 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. Forty-eight suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.
Summary for 206163
| Tradename: | LEVOTHYROXINE SODIUM |
| Applicant: | Piramal Critical |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 206163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 206163 | ANDA | Piramal Critical Care, Inc. | 66794-200 | 66794-200-02 | 5 mL in 1 VIAL, SINGLE-USE (66794-200-02) |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | POWDER;INTRAVENOUS | 206163 | ANDA | Piramal Critical Care, Inc. | 66794-201 | 66794-201-02 | 5 mL in 1 VIAL, SINGLE-USE (66794-201-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MCG/VIAL | ||||
| Approval Date: | Jun 29, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MCG/VIAL | ||||
| Approval Date: | Jun 29, 2016 | TE: | AP | RLD: | No | ||||
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