Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG | 0 | CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE |
| 002 | TABLET;ORAL | 500MG | 0 | CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 1975-07-09 | |
| BIOEQUIV; Bioequivalence | SUPPL | 21 | AP | 1989-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1991-04-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1997-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1997-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1997-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1997-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1997-09-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2000-05-24 | |
| LABELING; Labeling | SUPPL | 30 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-09-17 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1999-09-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1999-09-17 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2000-05-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2000-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2000-11-30 | |
| LABELING; Labeling | SUPPL | 40 | AP | 2000-11-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-07-11 | |
| LABELING; Labeling | SUPPL | 47 | AP | 2005-09-29 | |
| LABELING; Labeling | SUPPL | 48 | AP | 2006-03-21 | |
| LABELING; Labeling | SUPPL | 49 | AP | 2007-05-31 | |
| LABELING; Labeling | SUPPL | 50 | AP | 2009-11-10 | |
| LABELING; Labeling | SUPPL | 56 | AP | 2020-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2022-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2022-05-03 | STANDARD |
Submissions Property Types
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 50 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 7 |
| SUPPL | 58 | Null | 15 |
TE Codes
CDER Filings
HIKMA PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 83082
[companyName] => HIKMA PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"CHLOROQUINE PHOSPHATE","activeIngredients":"CHLOROQUINE PHOSPHATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHLOROQUINE PHOSPHATE","activeIngredients":"CHLOROQUINE PHOSPHATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/10\/2009","submission":"SUPPL-50","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/083082s050lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CHLOROQUINE PHOSPHATE","submission":"CHLOROQUINE PHOSPHATE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHLOROQUINE PHOSPHATE","submission":"CHLOROQUINE PHOSPHATE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-11-10
)
)