Details for New Drug Application (NDA): 213667
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NDA 213667 describes HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, Smith And Nephew, Solopak, Teva Parenteral, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, and Mylan, and is included in ninety-five NDAs. It is available from forty-three suppliers. Additional details are available on the HYDRALAZINE HYDROCHLORIDE profile page.
The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
The generic ingredient in HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 213667
| Tradename: | HYDRALAZINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | hydralazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213667
| Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for 213667
Suppliers and Packaging for NDA: 213667
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 213667 | ANDA | Henry Schein, Inc. | 0404-9994 | 0404-9994-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9994-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | INJECTABLE;INJECTION | 213667 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6231 | 0641-6231-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Dec 18, 2020 | TE: | AP | RLD: | No | ||||
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