Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086923
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2025 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/24/2002 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 12/07/1999 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 06/23/1997 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 07/11/1996 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 11/01/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 04/19/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/29/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
ISOSORBIDE DINITRATE
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 | 088088 | HIKMA INTL PHARMS |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 086923 | PH HEALTH |
| 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 |