Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216131
Company: HAINAN POLY
Company: HAINAN POLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/21/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 12.5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOBUTAMINE HYDROCHLORIDE | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216131 | HAINAN POLY |
DOBUTAMINE HYDROCHLORIDE | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074277 | HIKMA |
DOBUTAMINE HYDROCHLORIDE | DOBUTAMINE HYDROCHLORIDE | EQ 12.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074086 | HOSPIRA |