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Details for New Drug Application (NDA): 090576

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NDA 090576 describes NIZATIDINE, which is a drug marketed by Mylan Pharms Inc, Dr Reddys Labs Ltd, Watson Labs, Glenmark Generics, Ani Pharms Inc, Amneal Pharms, Sandoz, and Apotex Inc, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the NIZATIDINE profile page.

The generic ingredient in NIZATIDINE 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: 090576

Tradename:
NIZATIDINE
Applicant:
Amneal Pharms
Ingredient:
nizatidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090576

Suppliers and Packaging for NDA: 090576

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZATIDINE
nizatidine
SOLUTION;ORAL 090576 ANDA Gemini Laboratories, LLC 60846-301 60846-301-15 480 mL in 1 BOTTLE (60846-301-15)
NIZATIDINE
nizatidine
SOLUTION;ORAL 090576 ANDA Amneal Pharmaceuticals 65162-659 65162-659-90 480 mL in 1 BOTTLE (65162-659-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength15MG/ML
Approval Date:Nov 18, 2009TE:RLD:Yes


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