Documents
Application Sponsors
| NDA 017823 | SUN PHARM INDS INC | |
Marketing Status
Application Products
| 001 | SOLUTION;TOPICAL | 0.1% | 0 | HALOG | HALCINONIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1977-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 1980-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1979-01-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1979-04-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1980-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1980-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1980-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1980-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1981-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1983-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1984-05-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1984-08-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1985-01-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1985-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1988-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1989-06-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1992-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1996-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2004-09-29 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 17823
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"HALOG","activeIngredients":"HALCINONIDE","strength":"0.1%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
[labels] => [{"actionDate":"09\/29\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17823s023lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HALOG","submission":"HALCINONIDE","actionType":"0.1%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2004-09-29
)
)