Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.025%;0.3% | 1 | NAPHCON-A | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1994-06-08 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1995-02-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-11-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-11-01 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 1996-07-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-04-16 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 1996-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-12-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-08-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1999-12-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1999-06-14 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1999-10-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1999-11-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-01-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-03-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-09-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-03-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-06-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2015-07-31 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2019-04-11 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2022-12-19 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 22 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 29 | Null | 7 |
SUPPL | 35 | Null | 6 |
CDER Filings
ALCON
cder:Array
(
[0] => Array
(
[ApplNo] => 20226
[companyName] => ALCON
[docInserts] => ["",""]
[products] => [{"drugName":"NAPHCON-A","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","strength":"0.025%;0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/11\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020226Orig1s029lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NAPHCON-A","submission":"NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE","actionType":"0.025%;0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-11
)
)