Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 40MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 80MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 160MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 400MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 320MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE | 4MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/14/1984 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/26/2009 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019211s042ltr.pdf | |
| 10/31/2008 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019211s040ltr.pdf | |
| 11/01/2002 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/05/1996 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/13/1996 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/13/1992 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/02/1991 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/20/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/23/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1986 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/26/2009 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019211s042lbl.pdf | |
| 10/31/2008 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019211s040lbl.pdf |