Details for New Drug Application (NDA): 216131
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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 216131
Tradename: | DOBUTAMINE HYDROCHLORIDE |
Applicant: | Hainan Poly |
Ingredient: | dobutamine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216131
Mechanism of Action | Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for 216131
Suppliers and Packaging for NDA: 216131
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE | dobutamine hydrochloride | INJECTABLE;INJECTION | 216131 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-171 | 14335-171-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-171-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
DOBUTAMINE HYDROCHLORIDE | dobutamine hydrochloride | INJECTABLE;INJECTION | 216131 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-172 | 14335-172-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-172-01) / 40 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: | Dec 21, 2022 | TE: | AP | RLD: | No |
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