Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203110
Company: X-GEN PHARMS INC
Company: X-GEN PHARMS INC
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 |
---|---|---|---|---|---|---|---|
06/29/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203110Orig1s000ltr.pdf |
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 | 040730 | AKORN |
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 | 204680 | MYLAN INSTITUTIONAL |
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 | 203110 | X-GEN PHARMS INC |
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