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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202068

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NDA 202068 describes METHIMAZOLE, which is a drug marketed by Casi Pharms Inc, Eci Pharms Llc, Heritage Pharma, Mylan, Rising Pharms Inc, and Sun Pharm Inds Inc, and is included in seven NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the methimazole profile page.
Summary for 202068
Applicant:Rising Pharms Inc
Therapeutic Class:Hormonal Agents, Suppressant (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 202068
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 State of Florida DOH Central Pharmacy 53808-1044 E 53808-1044-1
METHIMAZOLE methimazole TABLET;ORAL 202068 ANDA Preferred Pharmaceuticals, Inc. 68788-0681 E 68788-0681-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 7, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 7, 2012TE:ABRLD:No

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