Details for New Drug Application (NDA): 077314
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NDA 077314 describes NIZATIDINE, which is a drug marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Epic Pharma Llc, Glenmark Generics, Mylan Pharms Inc, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
Summary for 077314
| Tradename: | NIZATIDINE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | nizatidine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077314
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077314
Suppliers and Packaging for NDA: 077314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIZATIDINE | nizatidine | CAPSULE;ORAL | 077314 | ANDA | Dr Reddy's Laboratories Limited | 55111-310 | 55111-310-01 | 100 CAPSULE in 1 BOTTLE (55111-310-01) |
| NIZATIDINE | nizatidine | CAPSULE;ORAL | 077314 | ANDA | Dr Reddy's Laboratories Limited | 55111-310 | 55111-310-05 | 500 CAPSULE in 1 BOTTLE (55111-310-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 15, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 15, 2005 | TE: | AB | RLD: | No | ||||
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