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FDA Approval

BISOPROLOL FUMARATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Alembic Pharmaceuticals Limited
DUNS: 650574663
Effective Date
February 7, 2023
Labeling Type
Human Prescription Drug Label
Bisoprolol(5 mg in 1 1)

Manufacturing Establishments1

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

Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited

650574671

Products2

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

BISOPROLOL FUMARATE

Product Details

NDC Product Code
46708-603
Application Number
ANDA204891
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2023
BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT

BISOPROLOL FUMARATE

Product Details

NDC Product Code
46708-604
Application Number
ANDA204891
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2023
BisoprololActive
Code: UR59KN573LClass: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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