Application Sponsors
| NDA 000552 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 007 |
| Discontinued | 008 |
| Discontinued | 009 |
| Discontinued | 010 |
| Discontinued | 011 |
| Discontinued | 012 |
| Discontinued | 013 |
Application Products
| 001 | INJECTABLE;INJECTION | 20,000 UNITS/ML | 0 | LIQUAEMIN SODIUM | HEPARIN SODIUM |
| 002 | INJECTABLE;INJECTION | 40,000 UNITS/ML | 0 | LIQUAEMIN SODIUM | HEPARIN SODIUM |
| 003 | INJECTABLE;INJECTION | 5,000 UNITS/ML | 0 | LIQUAEMIN SODIUM | HEPARIN SODIUM |
| 004 | INJECTABLE;INJECTION | 1,000 UNITS/ML | 0 | LIQUAEMIN SODIUM | HEPARIN SODIUM |
| 005 | INJECTABLE;INJECTION | 10,000 UNITS/ML | 0 | LIQUAEMIN SODIUM | HEPARIN SODIUM |
| 007 | INJECTABLE;INJECTION | 100 UNITS/ML | 0 | LIQUAEMIN LOCK FLUSH | HEPARIN SODIUM |
| 008 | INJECTABLE;INJECTION | 1,000 UNITS/ML | 0 | HEPARIN SODIUM | HEPARIN SODIUM |
| 009 | INJECTABLE;INJECTION | 5,000 UNITS/ML | 0 | HEPARIN SODIUM | HEPARIN SODIUM |
| 010 | INJECTABLE;INJECTION | 10,000 UNITS/ML | 0 | HEPARIN SODIUM | HEPARIN SODIUM |
| 011 | INJECTABLE;INJECTION | 1,000 UNITS/ML | 0 | LIQUAEMIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM |
| 012 | INJECTABLE;INJECTION | 5,000 UNITS/ML | 0 | LIQUAEMIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM |
| 013 | INJECTABLE;INJECTION | 10,000 UNITS/ML | 0 | LIQUAEMIN SODIUM PRESERVATIVE FREE | HEPARIN SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 1939-02-09 | UNKNOWN |
| REMS; REMS | SUPPL | 7 | AP | 1975-07-28 | |
| REMS; REMS | SUPPL | 8 | AP | 1975-07-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1978-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1981-06-08 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1978-01-25 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1981-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1980-11-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1980-11-28 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1985-05-13 | |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 1986-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-07-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1987-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-12-09 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1988-08-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1990-08-02 | |
Submissions Property Types
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 0 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 552
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HEPARIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN LOCK FLUSH","activeIngredients":"HEPARIN SODIUM","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"20,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"40,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM PRESERVATIVE FREE","activeIngredients":"HEPARIN SODIUM","strength":"1,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM PRESERVATIVE FREE","activeIngredients":"HEPARIN SODIUM","strength":"5,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIQUAEMIN SODIUM PRESERVATIVE FREE","activeIngredients":"HEPARIN SODIUM","strength":"10,000 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HEPARIN SODIUM","submission":"HEPARIN SODIUM","actionType":"1,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HEPARIN SODIUM","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN LOCK FLUSH","submission":"HEPARIN SODIUM","actionType":"100 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM","submission":"HEPARIN SODIUM","actionType":"20,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM","submission":"HEPARIN SODIUM","actionType":"40,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM","submission":"HEPARIN SODIUM","actionType":"1,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM PRESERVATIVE FREE","submission":"HEPARIN SODIUM","actionType":"1,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM PRESERVATIVE FREE","submission":"HEPARIN SODIUM","actionType":"5,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIQUAEMIN SODIUM PRESERVATIVE FREE","submission":"HEPARIN SODIUM","actionType":"10,000 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)