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FDA Approval

Nadolol

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

FDA Approval Summary

Company
Effective Date
April 28, 2025
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nadolol(40 mg in 1 1)

Manufacturing Establishments1

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

Golden State Medical Supply, Inc.

Golden State Medical Supply, Inc.

603184490

Products3

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

Nadolol

Product Details

NDC Product Code
51407-978
Application Number
ANDA210955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2025
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
NadololActive
Code: FEN504330VClass: ACTIBQuantity: 40 mg in 1 1

Nadolol

Product Details

NDC Product Code
51407-977
Application Number
ANDA210955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2025
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
NadololActive
Code: FEN504330VClass: ACTIBQuantity: 20 mg in 1 1

Nadolol

Product Details

NDC Product Code
51407-979
Application Number
ANDA210955
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 28, 2025
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
NadololActive
Code: FEN504330VClass: ACTIBQuantity: 80 mg in 1 1
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