Documents
Application Sponsors
| NDA 017555 | MERCK SHARP DOHME | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 10MG;100MG | 1 | SINEMET | CARBIDOPA; LEVODOPA |
| 002 | TABLET;ORAL | 25MG;250MG | 1 | SINEMET | CARBIDOPA; LEVODOPA |
| 003 | TABLET;ORAL | 25MG;100MG | 1 | SINEMET | CARBIDOPA; LEVODOPA |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 1975-05-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1978-01-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1978-01-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 1977-04-29 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1978-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1980-03-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1978-07-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1979-10-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 1980-03-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1980-01-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 1980-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1980-02-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1981-01-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 1980-09-09 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1981-09-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-06-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1981-08-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1983-05-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 1986-01-17 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1986-01-17 | |
| LABELING; Labeling | SUPPL | 25 | AP | 1986-01-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1984-09-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1984-05-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1984-03-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1985-05-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 30 | AP | 1985-07-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1985-07-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 1986-01-17 | |
| LABELING; Labeling | SUPPL | 33 | AP | 1986-01-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1988-02-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 35 | AP | 1988-04-21 | |
| LABELING; Labeling | SUPPL | 36 | AP | 2001-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2001-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 2001-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 39 | AP | 2001-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 40 | AP | 2001-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1995-07-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1996-05-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 2001-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1997-11-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1997-12-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1997-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 2001-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 2001-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2000-04-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2000-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 55 | AP | 2001-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 56 | AP | 2014-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2001-03-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 2001-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2001-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2001-03-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2001-10-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 2002-09-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 68 | AP | 2014-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2008-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 2011-02-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 71 | AP | 2014-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 72 | AP | 2020-03-03 | N/A |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 68 | Null | 6 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 71 | Null | 15 |
| SUPPL | 72 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MERCK SHARP DOHME
cder:Array
(
[0] => Array
(
[ApplNo] => 17555
[companyName] => MERCK SHARP DOHME
[docInserts] => ["",""]
[products] => [{"drugName":"SINEMET","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SINEMET","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"SINEMET","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/03\/2020","submission":"SUPPL-72","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/017555s072lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017555s056s068s071lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-68","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017555s056s068s071lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2014","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017555s056s068s071lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2011","submission":"SUPPL-70","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017555s070lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/31\/2008","submission":"SUPPL-69","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017555s069lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SINEMET","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SINEMET","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SINEMET","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-03-03
)
)