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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 204934


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NDA 204934 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in thirty NDAs. It is available from eight suppliers. Additional details are available on the NIACIN profile page.

The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 204934
Tradename:NIACIN
Applicant:Macleods Pharms Ltd
Ingredient:niacin
Patents:0
Pharmacology for NDA: 204934
Medical Subject Heading (MeSH) Categories for 204934
Suppliers and Packaging for NDA: 204934
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 204934 ANDA Macleods Pharmaceuticals Limited 33342-187 33342-187-10 90 TABLET in 1 BOTTLE (33342-187-10)
NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 204934 ANDA Macleods Pharmaceuticals Limited 33342-187 33342-187-11 100 TABLET in 1 BOTTLE (33342-187-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Mar 3, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Mar 3, 2022TE:ABRLD:No

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