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Generated: November 13, 2018

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Details for New Drug Application (NDA): 012945

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NDA 012945 describes DIAMOX, which is a drug marketed by Teva Branded Pharm and Teva Womens and is included in three NDAs. It is available from two suppliers. Additional details are available on the DIAMOX profile page.

The generic ingredient in DIAMOX is acetazolamide sodium. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.
Summary for 012945
Tradename:DIAMOX
Applicant:Teva Branded Pharm
Ingredient:acetazolamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 012945
Ingredient-typeSulfonamides
Mechanism of ActionCarbonic Anhydrase Inhibitors
Medical Subject Heading (MeSH) Categories for 012945
Suppliers and Packaging for NDA: 012945
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIAMOX acetazolamide CAPSULE, EXTENDED RELEASE;ORAL 012945 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0555-0513 0555-0513-02 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0555-0513-02)
DIAMOX acetazolamide CAPSULE, EXTENDED RELEASE;ORAL 012945 NDA Teva Women's Health, Inc. 51285-754 51285-754-02 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51285-754-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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