Details for New Drug Application (NDA): 088088
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NDA 088088 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Hikma Intl Pharms, Ph Health, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, MLV, and Novast Labs, and is included in thirty-three 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. 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 088088
| Tradename: | ISOSORBIDE DINITRATE |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | isosorbide dinitrate |
| Patents: | 0 |
Pharmacology for NDA: 088088
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 088088
Suppliers and Packaging for NDA: 088088
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 088088 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1772 | 0143-1772-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0143-1772-01) |
| ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 088088 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-1772 | 0143-1772-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1772-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 2, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 29, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 29, 1987 | TE: | AB | RLD: | No | ||||
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