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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 three 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. Three suppliers are listed for this compound. Additional details are available on the acetazolamide sodium profile page.

Summary for NDA: 012945

Tradename:
DIAMOX
Applicant:
Teva Branded Pharm
Ingredient:
acetazolamide
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 012945

Ingredient-typeSulfonamides
Mechanism of ActionCarbonic Anhydrase Inhibitors

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 Barr Laboratories 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)

Summary 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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