Details for New Drug Application (NDA): 090618
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NDA 090618 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 090618
| Tradename: | NIZATIDINE |
| Applicant: | Glenmark Pharms Inc |
| Ingredient: | nizatidine |
| Patents: | 0 |
Pharmacology for NDA: 090618
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 090618
Suppliers and Packaging for NDA: 090618
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIZATIDINE | nizatidine | CAPSULE;ORAL | 090618 | ANDA | Proficient Rx LP | 63187-249 | 63187-249-60 | 60 CAPSULE in 1 BOTTLE (63187-249-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 15, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jul 15, 2011 | TE: | AB | RLD: | No | ||||
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