Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213667
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/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 |
---|---|---|---|---|---|---|---|
12/18/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203110 | ADRASTEA PHARMA |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040136 | AM REGENT |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215147 | EUGIA PHARMA |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040388 | FRESENIUS KABI USA |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213667 | HIKMA |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202938 | NAVINTA LLC |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040730 | RISING |