Documents
Application Sponsors
ANDA 077612 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 200MG/5ML;40MG/5ML | 0 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM |
FDA Submissions
| ORIG | 1 | AP | 2006-11-13 | |
LABELING; Labeling | SUPPL | 2 | AP | 2007-11-01 | |
LABELING; Labeling | SUPPL | 5 | AP | 2012-08-13 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2021-10-25 | UNKNOWN |
Submissions Property Types
TE Codes
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77612
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"200MG\/5ML;40MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/13\/2012","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/077612s005lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"200MG\/5ML;40MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2012-08-13
)
)