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Generated: January 17, 2019

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Details for New Drug Application (NDA): 087672

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NDA 087672 describes METHYCLOTHIAZIDE, which is a drug marketed by Ivax Pharms, Mylan, Mylan Pharms Inc, Par Pharm, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in fifteen NDAs. It is available from one supplier. Additional details are available on the METHYCLOTHIAZIDE profile page.

The generic ingredient in METHYCLOTHIAZIDE is deserpidine; methyclothiazide. There are four drug master file entries for this compound. Additional details are available on the deserpidine; methyclothiazide profile page.
Summary for 087672
Applicant:Mylan Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 087672
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 087672
Suppliers and Packaging for NDA: 087672
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHYCLOTHIAZIDE methyclothiazide TABLET;ORAL 087672 ANDA Mylan Pharmaceuticals Inc. 0378-0160 0378-0160-01 100 TABLET in 1 BOTTLE (0378-0160-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 17, 1982TE:RLD:No

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