Details for New Drug Application (NDA): 076350
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NDA 076350 describes THYROSAFE, which is a drug marketed by Btg Intl and is included in one NDA. It is available from one supplier. Additional details are available on the THYROSAFE profile page.
The generic ingredient in THYROSAFE is potassium iodide. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium iodide profile page.
The generic ingredient in THYROSAFE is potassium iodide. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium iodide profile page.
Summary for 076350
| Tradename: | THYROSAFE |
| Applicant: | Btg Intl |
| Ingredient: | potassium iodide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076350
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THYROSAFE | potassium iodide | TABLET;ORAL | 076350 | ANDA | BTG International Inc. | 50633-910 | 50633-910-20 | 160 BOX in 1 CARTON (50633-910-20) / 20 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 65MG | ||||
| Approval Date: | Sep 10, 2002 | TE: | RLD: | No | |||||
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