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Generated: January 23, 2019

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Details for New Drug Application (NDA): 040378

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NDA 040378 describes NIACOR, which is a drug marketed by Avondale Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the NIACOR profile page.

The generic ingredient in NIACOR is niacin. There are fourteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 040378
Tradename:NIACOR
Applicant:Avondale Pharms
Ingredient:niacin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040378
Medical Subject Heading (MeSH) Categories for 040378
Suppliers and Packaging for NDA: 040378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACOR niacin TABLET;ORAL 040378 ANDA Upsher-Smith Laboratories, LLC 0245-0067 0245-0067-11 100 TABLET in 1 BOTTLE (0245-0067-11)
NIACOR niacin TABLET;ORAL 040378 ANDA Avondale Pharmaceuticals, LLC 71740-201 71740-201-10 100 TABLET in 1 BOTTLE (71740-201-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 3, 2000TE:AARLD:No

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