Details for New Drug Application (NDA): 075616
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NDA 075616 describes NIZATIDINE, which is a drug marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Pharms Inc, Mylan Pharms Inc, Norvium Bioscience, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from four 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. Four suppliers are listed for this compound. 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. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
Summary for 075616
| Tradename: | NIZATIDINE |
| Applicant: | Watson Labs |
| Ingredient: | nizatidine |
| Patents: | 0 |
Pharmacology for NDA: 075616
| Mechanism of Action | Histamine H2 Receptor Antagonists |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 9, 2002 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jul 9, 2002 | TE: | AB | RLD: | No | ||||
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