Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211290
Company: PAR PHARM INC
Company: PAR PHARM INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | 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 |
---|---|---|---|---|---|---|---|
11/23/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211290Orig1s000ltr.pdf |
ISOSORBIDE DINITRATE
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISORDIL | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 012093 | BAUSCH |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 211290 | PAR PHARM INC |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS |