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Details for New Drug Application (NDA): 087946
The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 087946
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Par Pharm |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Therapeutic Class: | Cardiovascular Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 087946
Ingredient-type | Nitrates |
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 087946
Suppliers and Packaging for NDA: 087946
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 087946 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-7584 | N | 0615-7584-39 |
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 087946 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8193 | N | 0615-8193-39 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jan 12, 1988 | TE: | AB | RLD: | No |
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