Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075037
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 10MG | 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 |
---|---|---|---|---|---|---|---|
10/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75037ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/17/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/24/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
ISOSORBIDE MONONITRATE
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 20MG | TABLET;ORAL | Prescription | No | AB | 075037 | ACTAVIS ELIZABETH |
MONOKET | ISOSORBIDE MONONITRATE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 020215 | OMNIVIUM PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 075037 | ACTAVIS ELIZABETH |
MONOKET | ISOSORBIDE MONONITRATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 020215 | OMNIVIUM PHARMS |