Details for New Drug Application (NDA): 040350
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The generic ingredient in METHIMAZOLE is methimazole. There are three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 040350
Tradename: | METHIMAZOLE |
Applicant: | Mylan |
Ingredient: | methimazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040350
Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 040350
Suppliers and Packaging for NDA: 040350
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHIMAZOLE | methimazole | TABLET;ORAL | 040350 | ANDA | Par Pharmaceutical, Inc. | 49884-640 | 49884-640-01 | 100 TABLET in 1 BOTTLE (49884-640-01) |
METHIMAZOLE | methimazole | TABLET;ORAL | 040350 | ANDA | Par Pharmaceutical, Inc. | 49884-640 | 49884-640-05 | 500 TABLET in 1 BOTTLE (49884-640-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 29, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 29, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 7, 2001 | TE: | RLD: | No |
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