Details for New Drug Application (NDA): 209827
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NDA 209827 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 fourteen 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 209827
| Tradename: | METHIMAZOLE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | methimazole |
| Patents: | 0 |
Pharmacology for NDA: 209827
| Mechanism of Action | Thyroid Hormone Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 209827
Suppliers and Packaging for NDA: 209827
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHIMAZOLE | methimazole | TABLET;ORAL | 209827 | ANDA | Macleods Pharmaceuticals Limited | 33342-335 | 33342-335-11 | 100 TABLET in 1 BOTTLE (33342-335-11) |
| METHIMAZOLE | methimazole | TABLET;ORAL | 209827 | ANDA | Macleods Pharmaceuticals Limited | 33342-335 | 33342-335-12 | 10 BLISTER PACK in 1 CARTON (33342-335-12) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 24, 2023 | TE: | AB | RLD: | No | ||||
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