Documents
Application Sponsors
| NDA 020212 | PHARMACIA AND UPJOHN | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | 1 | ZINECARD | DEXRAZOXANE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 1 | ZINECARD | DEXRAZOXANE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1995-05-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-05-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2002-10-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-10-31 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2002-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2012-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2014-04-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2016-01-06 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 41 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 14 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 14 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 20212
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"ZINECARD","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZINECARD","activeIngredients":"DEXRAZOXANE HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/18\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020212s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020212s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020212s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2002","submission":"SUPPL-6","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20212se7-004,005,006lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2002","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20212se7-004,005,006lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2002","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20212se7-004,005,006lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZINECARD","submission":"DEXRAZOXANE HYDROCHLORIDE","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZINECARD","submission":"DEXRAZOXANE HYDROCHLORIDE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2014-04-18
)
)