Details for New Drug Application (NDA): 216131
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NDA 216131 describes DOBUTAMINE HYDROCHLORIDE, which is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hospira, Luitpold, Slate Run Pharma, 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the dobutamine hydrochloride profile page.
Summary for 216131
| Tradename: | DOBUTAMINE HYDROCHLORIDE |
| Applicant: | Slate Run Pharma |
| Ingredient: | dobutamine hydrochloride |
| Patents: | 0 |
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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