Documents
Application Sponsors
| NDA 018337 | TARO PHARM INDS LTD | |
Marketing Status
| Over-the-counter | 001 |
| Over-the-counter | 002 |
| Over-the-counter | 003 |
| Over-the-counter | 004 |
Application Products
| 001 | SUPPOSITORY;RECTAL | 650MG | 1 | ACETAMINOPHEN | ACETAMINOPHEN |
| 002 | SUPPOSITORY;RECTAL | 325MG | 1 | ACETAMINOPHEN | ACETAMINOPHEN |
| 003 | SUPPOSITORY;RECTAL | 120MG | 1 | ACETAMINOPHEN | ACETAMINOPHEN |
| 004 | SUPPOSITORY;RECTAL | 80MG | 1 | INFANTS' FEVERALL | ACETAMINOPHEN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1980-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1988-06-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1992-08-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1994-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-09-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-10-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2007-11-02 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2008-06-27 | N/A |
| LABELING; Labeling | SUPPL | 28 | AP | 2010-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2010-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2014-01-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2015-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2015-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2020-02-07 | STANDARD |
Submissions Property Types
| SUPPL | 12 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
CDER Filings
TARO PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 18337
[companyName] => TARO PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"650MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"325MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"120MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"INFANTS' FEVERALL","activeIngredients":"ACETAMINOPHEN","strength":"80MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/07\/2020","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018337Orig1s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018337Orig1s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018337Orig1s032lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"650MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"325MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"120MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"INFANTS' FEVERALL","submission":"ACETAMINOPHEN","actionType":"80MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-02-07
)
)