Documents
Application Sponsors
| NDA 012104 | SUN PHARM INDS INC | |
Marketing Status
Application Products
| 001 | SPRAY;TOPICAL | 0.147MG/GM | 1 | KENALOG | TRIAMCINOLONE ACETONIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1974-10-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1974-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1976-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1977-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1977-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1977-10-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1977-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1978-07-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1979-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1979-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1980-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1982-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-10-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1985-06-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1985-08-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1987-06-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1992-09-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1997-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2001-10-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2009-08-20 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2011-08-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2013-06-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2013-11-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2015-10-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2017-01-26 | STANDARD |
Submissions Property Types
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | 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 | 32 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
TE Codes
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 12104
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"KENALOG","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.147MG\/GM","dosageForm":"SPRAY;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/01\/2011","submission":"SUPPL-32","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/012104s032lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
[originalApprovals] => [{"actionDate":"KENALOG","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.147MG\/GM","submissionClassification":"SPRAY;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2011-08-01
)
)