Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085863
Company: PRECISION DOSE
Company: PRECISION DOSE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | ELIXIR;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/16/1979 | 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 |
|---|---|---|---|---|---|
| 10/23/2000 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 01/14/1997 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1996 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 07/07/1992 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 04/23/1991 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/11/1991 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/28/1990 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 10/04/1989 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 02/08/1989 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1989 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/15/1988 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 03/17/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1983 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1970 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |