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Details for New Drug Application (NDA): 200484

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NDA 200484 describes NIACIN, which is a drug marketed by Everylife, Watson Labs, Sandoz, Impax Labs, Hikma Pharms Llc, Mk Labs, Wockhardt, Tablicaps, Lupin Ltd, Barr, Halsey, Purepac Pharm, Sun Pharma Global, Amneal Pharms, and Ivax Sub Teva Pharms, and is included in twenty-two NDAs. It is available from nine suppliers. Additional details are available on the NIACIN profile page.

The generic ingredient in NIACIN is niacin. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for NDA: 200484

Sun Pharma Global
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 200484

Ingredient-typeNicotinic Acids

Suppliers and Packaging for NDA: 200484

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, EXTENDED RELEASE;ORAL 200484 ANDA Sun Pharma Global FZE 47335-539 47335-539-08 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)
TABLET, EXTENDED RELEASE;ORAL 200484 ANDA Sun Pharma Global FZE 47335-539 47335-539-18 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 23, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Apr 23, 2014TE:ABRLD:No

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