Details for New Drug Application (NDA): 040411
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NDA 040411 describes METHIMAZOLE, which is a drug marketed by Bionpharma, Chartwell Rx, Discovery Therap, Heritage Pharma, Macleods Pharms Ltd, Mylan, Qingdao Baheal Pharm, Rising, and Sun Pharm Inds Inc, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the METHIMAZOLE profile page.
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.
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 040411
| Tradename: | METHIMAZOLE |
| Applicant: | Chartwell Rx |
| Ingredient: | methimazole |
| Patents: | 0 |
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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