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Propranolol Hydrochloride

PROPRANOLOL HYDROCHLORIDE Oral Solution 20 mg per 5 mL and 40 mg per 5 mL

Approved
Approval ID

2f69cab3-e04d-44ab-adb6-9d01169f4f00

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2012

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

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

Propranolol Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-0821
Application NumberANDA070979
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propranolol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2009
FDA Product Classification

INGREDIENTS (10)

PROPRANOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 5 mL
Code: F8A3652H1V
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALCOHOLInactive
Quantity: 30 uL in 5 mL
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Propranolol Hydrochloride - FDA Drug Approval Details