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Details for New Drug Application (NDA): 040320
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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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