Details for New Drug Application (NDA): 076187
NDA 076187 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 076187
| Tradename: | LEVOTHYROXINE SODIUM |
| Applicant: | Mylan |
| Ingredient: | levothyroxine sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076187
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187 | ANDA | Mylan Institutional Inc. | 42292-038 | 42292-038-20 | 100 BLISTER PACK in 1 CARTON (42292-038-20) / 1 TABLET in 1 BLISTER PACK (42292-038-01) |
| LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187 | ANDA | Mylan Institutional Inc. | 42292-039 | 42292-039-20 | 100 BLISTER PACK in 1 CARTON (42292-039-20) / 1 TABLET in 1 BLISTER PACK (42292-039-01) |
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: | Jun 5, 2002 | 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: | Jun 5, 2002 | 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: | Jun 5, 2002 | TE: | AB1,AB2,AB3,AB4 | RLD: | No | ||||
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