Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
Application Products
| 001 | TABLET;ORAL | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A |
| 002 | TABLET;ORAL | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A |
| 003 | TABLET;ORAL | 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A |
| 004 | TABLET;ORAL | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A |
| 005 | TABLET;ORAL | 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1999-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-11-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-11-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-01-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-03-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-01-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2002-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-07-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-09-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-09-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-09-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2002-06-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2002-04-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2004-02-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2002-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2004-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2004-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2015-03-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2020-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2020-11-30 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 7 |
| SUPPL | 39 | Null | 15 |
CDER Filings
ASPEN
cder:Array
(
[0] => Array
(
[ApplNo] => 20992
[companyName] => ASPEN
[docInserts] => ["",""]
[products] => [{"drugName":"CENESTIN","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CENESTIN","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CENESTIN","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CENESTIN","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CENESTIN","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/30\/2020","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020992s038s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2020","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020992s038s039lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020992s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2015","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020992s034lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2004","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20992s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2004","submission":"SUPPL-21","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20992se2-021_cenestin_lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2002","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20992s16lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20992lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CENESTIN","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CENESTIN","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CENESTIN","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CENESTIN","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CENESTIN","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-11-30
)
)