Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200495
Company: TORRENT PHARMS
Company: TORRENT PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
06/03/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075522 | DEXCEL LTD |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200495 | TORRENT PHARMS |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |
TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210822 | DEXCEL LTD |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200495 | TORRENT PHARMS |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |