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Details for New Drug Application (NDA): 040547

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NDA 040547 describes METHIMAZOLE, which is a drug marketed by Sandoz, Cedar Pharms, Heritage Pharma, Eci Pharms Llc, Mylan, Rising Pharms Inc, 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 NDA: 040547

Eci Pharms Llc
Therapeutic Class:Hormonal Agents, Suppressant (Thyroid)

Pharmacology for NDA: 040547

Suppliers and Packaging for NDA: 040547

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 040547 ANDA Exact-Rx, Inc. 42808-405 42808-405-01 100 TABLET in 1 BOTTLE (42808-405-01)
TABLET;ORAL 040547 ANDA Exact-Rx, Inc. 42808-410 42808-410-01 100 TABLET in 1 BOTTLE (42808-410-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 18, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 18, 2005TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Feb 18, 2005TE:RLD:No

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