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Generated: January 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075616

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NDA 075616 describes NIZATIDINE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Glenmark Generics, Mylan Pharms Inc, Sandoz, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
Summary for 075616
Applicant:Watson Labs
Formulation / Manufacturing:see details
Pharmacology for NDA: 075616
Medical Subject Heading (MeSH) Categories for 075616
Suppliers and Packaging for NDA: 075616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIZATIDINE nizatidine CAPSULE;ORAL 075616 ANDA Actavis Pharma, Inc. 0591-3137 0591-3137-60 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60)
NIZATIDINE nizatidine CAPSULE;ORAL 075616 ANDA Actavis Pharma, Inc. 0591-3138 0591-3138-30 30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jul 9, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Jul 9, 2002TE:ABRLD:No

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