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Generated: September 26, 2018

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Details for New Drug Application (NDA): 040350

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NDA 040350 describes METHIMAZOLE, which is a drug marketed by Casi Pharms Inc, Eci Pharms Llc, Heritage Pharma, Mylan, Rising Pharms, and Sun Pharm Inds Inc, and is included in seven NDAs. It is available from eighteen 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. Nineteen 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
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 Rebel Distributors Corp. 42254-008 42254-008-30 30 TABLET in 1 BOTTLE (42254-008-30)
METHIMAZOLE methimazole TABLET;ORAL 040350 ANDA Rebel Distributors Corp. 42254-009 42254-009-30 30 TABLET in 1 BOTTLE (42254-009-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 29, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 29, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Jun 7, 2001TE:RLD:No

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