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Details for New Drug Application (NDA): 040320
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NDA 040320 describes TAPAZOLE, which is a drug marketed by King Pharms and King Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the TAPAZOLE profile page.
The generic ingredient in TAPAZOLE is methimazole. There are three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
The generic ingredient in TAPAZOLE is methimazole. There are three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 040320
| Tradename: | TAPAZOLE |
| Applicant: | King Pharms Llc |
| Ingredient: | methimazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040320
| Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 040320
Suppliers and Packaging for NDA: 040320
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAPAZOLE | methimazole | TABLET;ORAL | 040320 | ANDA | Pfizer Laboratories Div Pfizer Inc | 60793-104 | 60793-104-01 | 100 TABLET in 1 BOTTLE (60793-104-01) |
| TAPAZOLE | methimazole | TABLET;ORAL | 040320 | ANDA | Pfizer Laboratories Div Pfizer Inc | 60793-105 | 60793-105-01 | 100 TABLET in 1 BOTTLE (60793-105-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 31, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 31, 2000 | TE: | AB | RLD: | No | ||||
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