Details for New Drug Application (NDA): 020201
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NDA 020201 describes DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Hospira and is included in two NDAs. It is available from three suppliers. Additional details are available on the DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 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 IN DEXTROSE 5% IN PLASTIC CONTAINER 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 020201
| Tradename: | DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Hospira |
| Ingredient: | dobutamine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020201
| Mechanism of Action | Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 020201
Suppliers and Packaging for NDA: 020201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | dobutamine hydrochloride | INJECTABLE;INJECTION | 020201 | NDA | Hospira, Inc. | 0409-2346 | 0409-2346-32 | 12 POUCH in 1 CASE (0409-2346-32) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2346-31) |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | dobutamine hydrochloride | INJECTABLE;INJECTION | 020201 | NDA | Hospira, Inc. | 0409-2347 | 0409-2347-32 | 12 POUCH in 1 CASE (0409-2347-32) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-2347-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 200MG BASE/100ML | ||||
| Approval Date: | Oct 19, 1993 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/100ML | ||||
| Approval Date: | Oct 19, 1993 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/100ML | ||||
| Approval Date: | Oct 19, 1993 | TE: | AP | RLD: | Yes | ||||
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