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Johnson and Johnson

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070259

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NDA 070259 describes TOLAZAMIDE, which is a drug marketed by Barr, Duramed Pharms Barr, G And W Labs Inc, Interpharm, Mylan Pharms Inc, Par Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in thirty NDAs. It is available from two suppliers. Additional details are available on the TOLAZAMIDE profile page.

The generic ingredient in TOLAZAMIDE is tolazamide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tolazamide profile page.
Summary for 070259
Applicant:Mylan Pharms Inc
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 070259
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 070259
Suppliers and Packaging for NDA: 070259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLAZAMIDE tolazamide TABLET;ORAL 070259 ANDA Mylan Pharmaceuticals Inc. 0378-0217 N 0378-0217-01
TOLAZAMIDE tolazamide TABLET;ORAL 070259 ANDA Mylan Pharmaceuticals Inc. 0378-0551 N 0378-0551-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 2, 1986TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 17, 1986TE:RLD:No

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