Details for New Drug Application (NDA): 215259
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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 215259
Tradename: | LEVOTHYROXINE SODIUM |
Applicant: | Ascent Pharms Inc |
Ingredient: | levothyroxine sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 215259
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 215259 | ANDA | Camber Pharmaceuticals, Inc. | 31722-284 | 31722-284-01 | 100 TABLET in 1 BOTTLE (31722-284-01) |
LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 215259 | ANDA | Camber Pharmaceuticals, Inc. | 31722-284 | 31722-284-10 | 1000 TABLET in 1 BOTTLE (31722-284-10) |
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: | Jan 18, 2023 | TE: | 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: | Jan 18, 2023 | TE: | 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: | Jan 18, 2023 | TE: | AB4 | RLD: | No |
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