Details for New Drug Application (NDA): 213057
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NDA 213057 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Endo Operations, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from twenty 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. Six 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. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 213057
| Tradename: | ISOSORBIDE DINITRATE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | isosorbide dinitrate |
| Patents: | 0 |
Pharmacology for NDA: 213057
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 213057
Suppliers and Packaging for NDA: 213057
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057 | ANDA | Northstar Rx LLC | 16714-007 | 16714-007-01 | 100 TABLET in 1 BOTTLE (16714-007-01) |
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 213057 | ANDA | Northstar Rx LLC | 16714-008 | 16714-008-01 | 100 TABLET in 1 BOTTLE (16714-008-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 20, 2019 | TE: | AB | RLD: | No | ||||
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