Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087209
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE | AMINOPHYLLINE | 25MG/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 |
|---|---|---|---|---|---|---|---|
| 02/01/1982 | 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 |
|---|---|---|---|---|---|
| 09/19/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/01/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |