Bisoprolol Fumarate

Registrants1

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

Zydus Lifesciences Limited

DUNS Number

650199482

Manufacturing Establishments1

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

Zydus Lifesciences Limited

Labeler

Viona Pharmaceuticals Inc

Registrant

Zydus Lifesciences Limited

DUNS Number

863362789

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

72578-112

Application Number

ANDA215680

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 10, 2023

Ingredients

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

BisoprololActive

Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

CROSPOVIDONE (12 MPA.S AT 5%)Inactive

Code: 40UAA97IT9Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT