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Details for New Drug Application (NDA): 202068

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NDA 202068 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 nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the methimazole profile page.

Summary for NDA: 202068

Tradename:
METHIMAZOLE
Applicant:
Rising Pharms Inc
Ingredient:
methimazole
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Thyroid)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 53808-1044-1 30 TABLET in 1 BLISTER PACK (53808-1044-1)
METHIMAZOLE
methimazole
TABLET;ORAL 202068 ANDA Boca Pharmacal, LLC 64376-655 64376-655-01 100 TABLET in 1 BOTTLE (64376-655-01)

Summary for product number 001

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

Summary for product number 002

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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