Details for New Drug Application (NDA): 040411
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The generic ingredient in METHIMAZOLE is methimazole. There are three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 040411
Tradename: | METHIMAZOLE |
Applicant: | Chartwell Rx |
Ingredient: | methimazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040411
Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 040411
Suppliers and Packaging for NDA: 040411
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHIMAZOLE | methimazole | TABLET;ORAL | 040411 | ANDA | Chartwell RX, LLC | 62135-205 | 62135-205-01 | 100 TABLET in 1 BOTTLE (62135-205-01) |
METHIMAZOLE | methimazole | TABLET;ORAL | 040411 | ANDA | Chartwell RX, LLC | 62135-205 | 62135-205-05 | 500 TABLET in 1 BOTTLE (62135-205-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 27, 2001 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 27, 2001 | TE: | AB | RLD: | No |
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