Application Sponsors
| ANDA 063336 | PHARMACHEMIE BV | |
Marketing Status
| Prescription | 001 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 2MG/ML | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 004 | INJECTABLE;INJECTION | 200MG/100ML | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1995-02-28 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1996-04-03 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1999-07-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-03-30 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2000-08-25 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2000-08-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-09-19 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
TE Codes
| 001 | Prescription | AP |
| 004 | Prescription | AP |
CDER Filings
PHARMACHEMIE BV
cder:Array
(
[0] => Array
(
[ApplNo] => 63336
[companyName] => PHARMACHEMIE BV
[docInserts] => ["",""]
[products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)