Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215586
Company: RICONPHARMA LLC
Company: RICONPHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | 37.5MG;20MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/06/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215586Orig1s000ltr.pdf |
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL; 37.5MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BIDIL | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | 37.5MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 020727 | AZURITY |
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | 37.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 215988 | I3 PHARMS |
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | 37.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 215586 | RICONPHARMA LLC |