Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083724
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOPROTERENOL HYDROCHLORIDE | ISOPROTERENOL HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/1976 | 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 |
|---|---|---|---|---|---|
| 07/16/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |