Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012093
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISORDIL | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
ISORDIL | ISOSORBIDE DINITRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
ISORDIL | ISOSORBIDE DINITRATE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
ISORDIL | ISOSORBIDE DINITRATE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
ISORDIL | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
11/09/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/14/2015 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012093Orig1s052ltr.pdf | |
11/20/2014 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2001 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12093s44ltr.pdf |
06/16/1999 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
10/16/1991 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
07/29/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
02/16/1989 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/14/2015 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012093s052lbl.pdf |
ISORDIL
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 | ENDO OPERATIONS |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISORDIL | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 012093 | BAUSCH |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086923 | ENDO OPERATIONS |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086067 | HIKMA INTL PHARMS |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 215723 | RUBICON |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086221 | SANDOZ |
ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 213057 | ZYDUS LIFESCIENCES |