Details for New Drug Application (NDA): 215723
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NDA 215723 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Hikma Intl Pharms, Par Pharm, Par Pharm Inc, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from nineteen suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.
The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 215723
| Tradename: | ISOSORBIDE DINITRATE |
| Applicant: | Rubicon |
| Ingredient: | isosorbide dinitrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215723
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 215723
Suppliers and Packaging for NDA: 215723
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 215723 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8463 | 0615-8463-39 | 30 TABLET in 1 BLISTER PACK (0615-8463-39) |
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 215723 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8464 | 0615-8464-39 | 30 TABLET in 1 BLISTER PACK (0615-8464-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 8, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 8, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 8, 2022 | TE: | AB | RLD: | No | ||||
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