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Details for New Drug Application (NDA): 086066

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NDA 086066 describes ISOSORBIDE DINITRATE, which is a drug marketed by Sun Pharm Inds, Sun Pharm Inds Inc, Sandoz, Corepharma, Par Pharm, Watson Labs, Hikma Intl Pharms, and Superpharm, and is included in thirty-one NDAs. It is available from twenty-five suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

Summary for NDA: 086066

Hikma Intl Pharms
isosorbide dinitrate
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 086066

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 086066

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
isosorbide dinitrate
TABLET;ORAL 086066 ANDA West-Ward Pharmaceuticals Corp 0143-1771 0143-1771-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01)
isosorbide dinitrate
TABLET;ORAL 086066 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1560 0615-1560-39 30 TABLET in 1 BLISTER PACK (0615-1560-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 29, 1987TE:ABRLD:No

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