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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204691

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NDA 204691 describes ACETAZOLAMIDE, which is a drug marketed by Zydus Pharms Usa Inc, Alra, Heritage Pharma, Novast Labs Ltd, Lannett, Mutual Pharm, Sun Pharm Inds, Vangard, Heritage Pharms Inc, Watson Labs, Ascot, Nostrum Labs Inc, Taro, Hospira, Par Sterile Products, Sagent Agila, X Gen Pharms, West-ward Pharms Int, and Emcure Pharms Ltd, and is included in twenty NDAs. It is available from seventeen suppliers. Additional details are available on the ACETAZOLAMIDE profile page.

The generic ingredient in ACETAZOLAMIDE 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 NDA: 204691

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

Pharmacology for NDA: 204691

Ingredient-typeSulfonamides
Mechanism of ActionCarbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 204691

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAZOLAMIDE
acetazolamide
CAPSULE, EXTENDED RELEASE;ORAL 204691 ANDA Nostrum Laboratories, Inc. 29033-030 29033-030-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-030-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Mar 29, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
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Queensland Health

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