Details for New Drug Application (NDA): 076178
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The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
Summary for 076178
Tradename: | NIZATIDINE |
Applicant: | Epic Pharma Llc |
Ingredient: | nizatidine |
Patents: | 0 |
Pharmacology for NDA: 076178
Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 076178
Suppliers and Packaging for NDA: 076178
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIZATIDINE | nizatidine | CAPSULE;ORAL | 076178 | ANDA | Epic Pharma, LLC | 42806-299 | 42806-299-30 | 30 CAPSULE in 1 BOTTLE (42806-299-30) |
NIZATIDINE | nizatidine | CAPSULE;ORAL | 076178 | ANDA | Epic Pharma, LLC | 42806-299 | 42806-299-60 | 60 CAPSULE in 1 BOTTLE (42806-299-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
Approval Date: | Jul 5, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Jul 5, 2002 | TE: | AB | RLD: | No |
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