Details for New Drug Application (NDA): 074086
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NDA 074086 describes DOBUTAMINE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hainan Poly, Hikma, Hospira, Luitpold, Teligent, Teva Parenteral, Watson Labs, and Watson Labs Inc, and is included in fifteen NDAs. It is available from five suppliers. Additional details are available on the DOBUTAMINE HYDROCHLORIDE profile page.
The generic ingredient in DOBUTAMINE HYDROCHLORIDE is dobutamine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.
The generic ingredient in DOBUTAMINE HYDROCHLORIDE is dobutamine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.
Summary for 074086
| Tradename: | DOBUTAMINE HYDROCHLORIDE |
| Applicant: | Hospira |
| Ingredient: | dobutamine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074086
| Mechanism of Action | Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 074086
Suppliers and Packaging for NDA: 074086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOBUTAMINE HYDROCHLORIDE | dobutamine hydrochloride | INJECTABLE;INJECTION | 074086 | ANDA | Hospira, Inc. | 0409-2344 | 0409-2344-88 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68) |
| DOBUTAMINE HYDROCHLORIDE | dobutamine hydrochloride | INJECTABLE;INJECTION | 074086 | ANDA | Hospira, Inc. | 0409-2344 | 0409-2344-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 12.5MG BASE/ML | ||||
| Approval Date: | Nov 29, 1993 | TE: | AP | RLD: | No | ||||
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