Bisoprolol fumarate

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Prinston Pharmaceutical Inc.

DUNS Number

967289799

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

GENERICS BIDCO II, LLC

Labeler

Solco Healthcare US, LLC

Registrant

Prinston Pharmaceutical Inc.

DUNS Number

151228897

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

43547-617

Application Number

ANDA217368

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 26, 2023

Ingredients

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEPClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT