Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087727
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOPHYLLINE DYE FREE | AMINOPHYLLINE | 105MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 04/16/1982 | 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 |
|---|---|---|---|---|---|
| 11/13/2000 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 07/26/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/03/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/05/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/16/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/02/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/31/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/14/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/14/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |