Documents
Application Sponsors
NDA 215712 | PERRIGO PHARMA INTL | |
Marketing Status
Application Products
001 | SPRAY, METERED;NASAL | 0.05MG/SPRAY | 1 | NASONEX 24HR ALLERGY | MOMETASONE FUROATE |
FDA Submissions
TYPE 8; Type 8 - Partial Rx to OTC Switch | ORIG | 1 | AP | 2022-03-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2022-07-15 | N/A |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2022-09-16 | N/A |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2022-07-15 | N/A |
LABELING; Labeling | SUPPL | 7 | AP | 2022-09-20 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2022-09-20 | STANDARD |
LABELING; Labeling | SUPPL | 11 | TA | 2022-09-19 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 7 | Null | 6 |
SUPPL | 8 | Null | 7 |
CDER Filings
PERRIGO PHARMA INTL
cder:Array
(
[0] => Array
(
[ApplNo] => 215712
[companyName] => PERRIGO PHARMA INTL
[docInserts] => ["",""]
[products] => [{"drugName":"NASONEX 24HR ALLERGY","activeIngredients":"MOMETASONE FUROATE","strength":"50MCG","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215712Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 8 - Partial Rx to OTC Switch","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215712Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215712Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-03-17
)
)