Details for New Drug Application (NDA): 218070
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NDA 218070 describes LIOTHYRONINE SODIUM, which is a drug marketed by Xgen Pharms, Biocon Pharma, Dr Reddys Labs Sa, Norvium Bioscience, Sigmapharm Labs Llc, Sun Pharm, Teva Pharms Usa, Watson Labs, and Zydus Lifesciences, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the LIOTHYRONINE SODIUM profile page.
The generic ingredient in LIOTHYRONINE SODIUM is liothyronine sodium. There are four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.
The generic ingredient in LIOTHYRONINE SODIUM is liothyronine sodium. There are four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.
Summary for 218070
| Tradename: | LIOTHYRONINE SODIUM |
| Applicant: | Biocon Pharma |
| Ingredient: | liothyronine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218070
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIOTHYRONINE SODIUM | liothyronine sodium | TABLET;ORAL | 218070 | ANDA | Biocon Pharma Inc. | 70377-114 | 70377-114-11 | 90 TABLET in 1 BOTTLE (70377-114-11) |
| LIOTHYRONINE SODIUM | liothyronine sodium | TABLET;ORAL | 218070 | ANDA | Biocon Pharma Inc. | 70377-114 | 70377-114-12 | 100 TABLET in 1 BOTTLE (70377-114-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.005MG BASE | ||||
| Approval Date: | Feb 6, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.025MG BASE | ||||
| Approval Date: | Feb 6, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.05MG BASE | ||||
| Approval Date: | Feb 6, 2024 | TE: | AB | RLD: | No | ||||
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