Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL | 1 | GEMZAR | GEMCITABINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 1 | GEMZAR | GEMCITABINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1996-05-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1997-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-10-10 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 1997-09-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 1998-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1998-01-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1998-10-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 10 | AP | 2000-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-11-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 2003-01-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-03-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-06-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-06-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-01-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-11-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-05-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2002-05-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-11-13 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2004-05-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2005-04-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2005-04-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 37 | AP | 2006-04-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2006-07-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 64 | AP | 2010-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2011-02-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 72 | AP | 2013-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | AP | 2014-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 2014-08-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 77 | AP | 2014-05-08 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 79 | AP | 2017-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 80 | AP | 2018-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 81 | AP | 2018-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 82 | AP | 2019-05-14 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 33 | Null | 8 |
| SUPPL | 64 | Null | 7 |
| SUPPL | 69 | Null | 6 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 75 | Null | 6 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 15 |
| SUPPL | 79 | Null | 7 |
| SUPPL | 80 | Null | 15 |
| SUPPL | 81 | Null | 6 |
| SUPPL | 82 | Null | 6 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20509
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)