Drugs@FDA: FDA-Approved Drugs
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE | AMINOPHYLLINE | 100MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/1975 | 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 |
|---|---|---|---|---|---|
| 07/18/2002 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/2001 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/25/2001 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/2000 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/26/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1994 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1991 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1990 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/27/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/04/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |