Details for New Drug Application (NDA): 076187
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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 076187
Tradename: | LEVOTHYROXINE SODIUM |
Applicant: | Mylan |
Ingredient: | levothyroxine sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 Pharmaceuticals Inc. | 0378-1800 | 0378-1800-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-1800-10) |
LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 076187 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1800 | 0378-1800-77 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-1800-77) |
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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