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Details for New Drug Application (NDA): 070259

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NDA 070259 describes TOLAZAMIDE, which is a drug marketed by Watson Labs, Sandoz, Usl Pharma, Sun Pharm Inds, Mylan Pharms Inc, Par Pharm, Barr, Superpharm, Duramed Pharms Barr, Interpharm, and G And W Labs Inc, 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 NDA: 070259

Mylan Pharms Inc
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 070259

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 070259

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 070259 ANDA Mylan Pharmaceuticals Inc. 0378-0217 0378-0217-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0217-01)
TABLET;ORAL 070259 ANDA Mylan Pharmaceuticals Inc. 0378-0551 0378-0551-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0551-01)

Summary for product number 001

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 17, 1986TE:RLD:Yes

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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.