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isosorbide mononitrate

Isosorbide MononitrateExtended-Release TabletsRx only

Approved
Approval ID

b14942c1-6162-4582-bc2c-2ff07a344dbd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2018

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

isosorbide mononitrate

PRODUCT DETAILS

NDC Product Code50090-2077
Application NumberANDA075155
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 12, 2016
Generic Nameisosorbide mononitrate

INGREDIENTS (1)

ISOSORBIDE MONONITRATEActive
Quantity: 60 mg in 1 1
Code: LX1OH63030
Classification: ACTIB

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isosorbide mononitrate - FDA Drug Approval Details