Documents
Application Sponsors
| NDA 016979 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEGACE | MEGESTROL ACETATE |
| 002 | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MEGACE | MEGESTROL ACETATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1971-08-18 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 1975-06-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1976-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1976-07-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1976-09-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1976-11-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1976-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1977-06-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1979-06-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1980-02-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1981-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1982-02-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1984-07-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1984-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1982-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1990-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1984-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1985-07-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1990-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 1987-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 1985-11-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1988-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1988-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1988-04-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1989-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 1989-08-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1989-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1991-03-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1991-03-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1993-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 1994-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 1997-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 1999-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2001-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2001-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2002-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2003-01-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | 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 | 19 | 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 | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 16979
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"MEGACE","activeIngredients":"MEGESTROL ACETATE","strength":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MEGACE","activeIngredients":"MEGESTROL ACETATE","strength":"40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"MEGACE","submission":"MEGESTROL ACETATE","actionType":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MEGACE","submission":"MEGESTROL ACETATE","actionType":"40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)