Details for New Drug Application (NDA): 202068
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NDA 202068 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 202068
| Tradename: | METHIMAZOLE |
| Applicant: | Rising |
| Ingredient: | methimazole |
| Patents: | 0 |
Pharmacology for NDA: 202068
| Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 202068
Suppliers and Packaging for NDA: 202068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHIMAZOLE | methimazole | TABLET;ORAL | 202068 | ANDA | Rising Pharmaceuticals, Inc. | 64980-264 | 64980-264-01 | 100 TABLET in 1 BOTTLE (64980-264-01) |
| METHIMAZOLE | methimazole | TABLET;ORAL | 202068 | ANDA | Rising Pharmaceuticals, Inc. | 64980-265 | 64980-265-01 | 100 TABLET in 1 BOTTLE (64980-265-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 7, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 7, 2012 | TE: | AB | RLD: | No | ||||
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