Details for New Drug Application (NDA): 200295
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NDA 200295 describes LIOTHYRONINE SODIUM, which is a drug marketed by Xgen Pharms, Biocon Pharma, Dr Reddys Labs Sa, Mylan, Sigmapharm Labs Llc, Sun Pharm, Teva Pharms Usa, Watson Labs, and Zydus, and is included in ten NDAs. It is available from eighteen 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 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 suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.
Summary for 200295
| Tradename: | LIOTHYRONINE SODIUM |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | liothyronine sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 200295
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIOTHYRONINE SODIUM | liothyronine sodium | TABLET;ORAL | 200295 | ANDA | AvKARE | 42291-418 | 42291-418-90 | 90 TABLET in 1 BOTTLE (42291-418-90) |
| LIOTHYRONINE SODIUM | liothyronine sodium | TABLET;ORAL | 200295 | ANDA | SIGMAPHARM LABORATORIES, LLC | 42794-018 | 42794-018-02 | 100 TABLET in 1 BOTTLE (42794-018-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.005MG BASE | ||||
| Approval Date: | Nov 29, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.025MG BASE | ||||
| Approval Date: | Nov 29, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.05MG BASE | ||||
| Approval Date: | Nov 29, 2012 | TE: | AB | RLD: | No | ||||
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