Details for New Drug Application (NDA): 207707
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NDA 207707 describes DOPAMINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Am Regent, Baxter Hlthcare, Hikma Intl Pharms, Hospira, Igi Labs Inc, Intl Medication, Lyphomed, Smith And Nephew, Teligent, Teva Parenteral, Warner Chilcott, and B Braun, and is included in thirty-six NDAs. It is available from six suppliers. Additional details are available on the DOPAMINE HYDROCHLORIDE profile page.
The generic ingredient in DOPAMINE HYDROCHLORIDE is dopamine hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dopamine hydrochloride profile page.
The generic ingredient in DOPAMINE HYDROCHLORIDE is dopamine hydrochloride. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dopamine hydrochloride profile page.
Summary for 207707
| Tradename: | DOPAMINE HYDROCHLORIDE |
| Applicant: | Hikma Intl Pharms |
| Ingredient: | dopamine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207707
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOPAMINE HYDROCHLORIDE | dopamine hydrochloride | INJECTABLE;INJECTION | 207707 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9252 | 0143-9252-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9252-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9252-01) |
| DOPAMINE HYDROCHLORIDE | dopamine hydrochloride | INJECTABLE;INJECTION | 207707 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9253 | 0143-9253-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9253-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9253-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Apr 11, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/ML | ||||
| Approval Date: | Apr 11, 2018 | TE: | AP | RLD: | No | ||||
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