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Last Updated: November 21, 2024

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 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.
Summary for 209827
Tradename:METHIMAZOLE
Applicant:Macleods Pharms Ltd
Ingredient:methimazole
Patents:0
Pharmacology for NDA: 209827
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:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 24, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 24, 2023TE:ABRLD:No

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