Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | Film, Extended Release; Transdermal | 11MG/24HR | 0 | PROSTEP | NICOTINE |
002 | Film, Extended Release; Transdermal | 22MG/24HR | 0 | PROSTEP | NICOTINE |
003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 11MG/24HR | 0 | PROSTEP | NICOTINE |
004 | FILM, EXTENDED RELEASE;TRANSDERMAL | 22MG/24HR | 0 | PROSTEP | NICOTINE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-01-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1993-04-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1993-02-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-02-02 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 1996-01-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-12-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 12 | AP | 1998-12-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-04-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-05-07 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2002-01-18 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2002-10-04 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
CDER Filings
AVEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 19983
[companyName] => AVEVA
[docInserts] => ["",""]
[products] => [{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"11MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"22MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"11MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROSTEP","activeIngredients":"NICOTINE","strength":"22MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"01\/18\/2002","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19983s16lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"11MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"22MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"11MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROSTEP","submission":"NICOTINE","actionType":"22MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2002-01-18
)
)