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Details for New Drug Application (NDA): 090618

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NDA 090618 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: 090618

Glenmark Generics
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 090618

Suppliers and Packaging for NDA: 090618

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 090618 ANDA Medsource Pharmaceuticals 45865-374 45865-374-60 60 CAPSULE in 1 BOTTLE (45865-374-60)
CAPSULE;ORAL 090618 ANDA A-S Medication Solutions 54569-5924 54569-5924-0 60 CAPSULE in 1 BOTTLE (54569-5924-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jul 15, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 15, 2011TE:ABRLD:No

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