Documents
Application Sponsors
| NDA 018261 | PAR STERILE PRODUCTS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 10USP UNITS/ML (10USP UNITS/ML) | 1 | PITOCIN | OXYTOCIN |
| 002 | INJECTABLE;INJECTION | 100USP UNITS/10ML (10USP UNITS/ML) | 1 | PITOCIN | OXYTOCIN |
| 003 | INJECTABLE;INJECTION | 500USP UNITS/50ML (10USP UNITS/ML) | 1 | PITOCIN | OXYTOCIN |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1980-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1986-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1988-02-16 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1990-07-03 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1994-08-09 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1994-08-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1994-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1996-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1997-07-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1999-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1999-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2000-03-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-03-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-10-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-03-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2001-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2002-01-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2001-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2003-03-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2007-07-27 | N/A |
| LABELING; Labeling | SUPPL | 31 | AP | 2014-10-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2014-06-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2016-08-15 | N/A |
| LABELING; Labeling | SUPPL | 41 | AP | 2021-05-11 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 12 | 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 | 22 | Null | 0 |
| SUPPL | 31 | Null | 7 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 41 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
PAR STERILE PRODUCTS
cder:Array
(
[0] => Array
(
[ApplNo] => 18261
[companyName] => PAR STERILE PRODUCTS
[docInserts] => ["",""]
[products] => [{"drugName":"PITOCIN","activeIngredients":"OXYTOCIN","strength":"10USP UNITS\/ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PITOCIN","activeIngredients":"OXYTOCIN","strength":"100USP UNITS\/10ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PITOCIN","activeIngredients":"OXYTOCIN","strength":"500USP UNITS\/50ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/02\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018261s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2007","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018261s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2007","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018261s028lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PITOCIN","submission":"OXYTOCIN","actionType":"10USP UNITS\/ML (10USP UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PITOCIN","submission":"OXYTOCIN","actionType":"100USP UNITS\/10ML (10USP UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PITOCIN","submission":"OXYTOCIN","actionType":"500USP UNITS\/50ML (10USP UNITS\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-10-02
)
)