Application Sponsors
| ANDA 063097 | PHARMACHEMIE BV | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 20MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
| 003 | INJECTABLE;INJECTION | 50MG/VIAL | 0 | DOXORUBICIN HYDROCHLORIDE | DOXORUBICIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1990-05-21 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1992-03-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1992-03-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-07-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1996-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1996-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-01-29 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1996-01-29 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-06-07 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1999-07-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-03-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-02-15 | |
| LABELING; Labeling | SUPPL | 16 | AP | 2000-08-25 | |
| LABELING; Labeling | SUPPL | 17 | AP | 2000-08-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-09-19 | |
| LABELING; Labeling | SUPPL | 19 | AP | 2002-09-18 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2003-08-14 | |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
PHARMACHEMIE BV
cder:Array
(
[0] => Array
(
[ApplNo] => 63097
[companyName] => PHARMACHEMIE BV
[docInserts] => ["",""]
[products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)