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FDA Approval

Coreg CR

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

FDA Approval Summary

Company
Effective Date
December 19, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Carvedilol(80 mg in 1 1)

Manufacturing Establishments3

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

Recipharm Pessac S.A.S.

Waylis Therapeutics LLC

871401927

Bora Pharmaceuticals

Waylis Therapeutics LLC

205556368

Future Pak LLC

Waylis Therapeutics LLC

087737672

Products4

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

Coreg CR

Product Details

NDC Product Code
80725-388
Application Number
NDA022012
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 31, 2023
Code: EQT531S367Class: ACTIBQuantity: 80 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT

Coreg CR

Product Details

NDC Product Code
80725-383
Application Number
NDA022012
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 31, 2023
Code: EQT531S367Class: ACTIBQuantity: 10 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT

Coreg CR

Product Details

NDC Product Code
80725-387
Application Number
NDA022012
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 31, 2023
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
Code: EQT531S367Class: ACTIBQuantity: 40 mg in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT

Coreg CR

Product Details

NDC Product Code
80725-385
Application Number
NDA022012
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 31, 2023
Code: EQT531S367Class: ACTIBQuantity: 20 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
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