MedPath

Nadolol

NADOLOL TABLETS USPRx only

Approved
Approval ID

0c6eed96-edfd-4e65-8eff-59d1ad51a59a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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

Nadolol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-094
Application NumberANDA074229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nadolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2011
FDA Product Classification

INGREDIENTS (6)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
NadololActive
Quantity: 20 mg in 1 1
Code: FEN504330V
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

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Nadolol - FDA Drug Approval Details