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Details for New Drug Application (NDA): 020555

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NDA 020555 describes AXID AR, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the AXID AR profile page.

The generic ingredient in AXID AR is nizatidine. There are seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

Summary for NDA: 020555

Tradename:
AXID AR
Applicant:
Pfizer
Ingredient:
nizatidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020555

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AXID AR
nizatidine
TABLET;ORAL 020555 NDA Pfizer Consumer Healthcare 0573-2400 0573-2400-45 1 BOTTLE, PLASTIC in 1 CARTON (0573-2400-45) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength75MG
Approval Date:May 9, 1996TE:RLD:Yes

Expired Orange Book Patents for NDA: 020555

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
AXID AR
nizatidine
TABLET;ORAL020555-001May 9, 19964,375,547► subscribe
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