Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
Application Products
| 001 | INJECTABLE;INJECTION | 40MG/100ML | 1 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 002 | INJECTABLE;INJECTION | 80MG/100ML | 0 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 003 | INJECTABLE;INJECTION | 160MG/100ML | 1 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 004 | INJECTABLE;INJECTION | 200MG/100ML | 0 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 005 | INJECTABLE;INJECTION | 400MG/100ML | 0 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 006 | INJECTABLE;INJECTION | 320MG/100ML | 1 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
| 007 | INJECTABLE;INJECTION | 4MG/ML | 1 | THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER | THEOPHYLLINE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1984-12-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1992-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1986-10-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1988-01-20 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1988-01-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1990-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1992-03-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1991-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1996-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1996-07-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-08-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-02-13 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1996-02-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-07-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1997-07-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1998-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2008-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2009-03-26 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
CDER Filings
HOSPIRA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19211
[companyName] => HOSPIRA INC
[docInserts] => ["",""]
[products] => [{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"40MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"80MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"160MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"400MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"320MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/26\/2009","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019211s042lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2008","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019211s040lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"40MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"80MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"160MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"320MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"4MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2009-03-26
)
)