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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040784

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NDA 040784 describes ACETAZOLAMIDE SODIUM, which is a drug marketed by Hospira, Par Sterile Products, Sagent Agila, West-ward Pharms Int, X Gen Pharms, and Emcure Pharms Ltd, and is included in six NDAs. It is available from four suppliers. Additional details are available on the ACETAZOLAMIDE SODIUM profile page.

The generic ingredient in ACETAZOLAMIDE SODIUM is acetazolamide sodium. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.

Summary for 040784

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040784

Ingredient-typeSulfonamides
Mechanism of ActionCarbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 040784

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 040784 ANDA X-GEN Pharmaceuticals, Inc. 39822-0190 39822-0190-1 1 VIAL, GLASS in 1 CARTON (39822-0190-1) > 5 mL in 1 VIAL, GLASS
ACETAZOLAMIDE SODIUM acetazolamide sodium INJECTABLE;INJECTION 040784 ANDA X-GEN Pharmaceuticals, Inc. 39822-0191 39822-0191-9 1 VIAL in 1 CARTON (39822-0191-9) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 10, 2008TE:APRLD:No


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