01 1Acebright India Pharma Private Limited
02 1Alembic Pharmaceuticals Limited
03 1Apotex Pharmachem
04 1Asymchem Laboratories
05 1Cambrex Corporation
06 1Cdymax
07 1Cipla
08 1Esteve Huayi Pharmaceutical
09 1F.I.S. Fabbrica Italiana Sintetici
10 1Hetero Drugs
11 1Hikma Pharmaceuticals
12 1Intas Pharmaceuticals
13 1Laurus Labs
14 2MSN Laboratories
15 1Natco Pharma
16 1Qilu Antibiotics Pharmaceutical Co., Ltd.
17 1Reliance Life Sciences Private Limited
18 1Shilpa Medicare
19 1Sichuan Xieli Pharmaceutical
20 1Sun Pharmaceutical Industries Limited
21 1TAPI Technology & API Services
22 1Tai Heng Industry Co., Ltd
23 2Viatris
24 1Zhejiang Jiuzhou Pharmaceutical
25 2Zydus Lifesciences
01 1ERLOTINIB HYDROCHLORIDE
02 1ERLOTINIB HCL
03 19ERLOTINIB HYDROCHLORIDE
04 1ERLOTINIB HYDROCHLORIDE (ET)
05 1ERLOTINIB HYDROCHLORIDE (FORM-A)
06 2ERLOTINIB HYDROCHLORIDE (FORM-B)
07 1ERLOTINIB HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)
08 1ERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)]
09 1ERLOTINIB HYDROCHLORIDE [ROUTE CODE - "ER"]
01 1Canada
02 5China
03 15India
04 1Israel
05 1Italy
06 4U.S.A
07 1United Kingdom
01 19Active
02 9Inactive
01 17Complete
02 11Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2012-12-12
DMF Number : 26631
Submission : 2013-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-16
Pay. Date : 2018-09-24
DMF Number : 29638
Submission : 2015-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-08
Pay. Date : 2016-04-22
DMF Number : 26116
Submission : 2012-06-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29437
Submission : 2015-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-08
Pay. Date : 2015-09-23
DMF Number : 27042
Submission : 2013-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-09
Pay. Date : 2015-05-27
DMF Number : 21786
Submission : 2008-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-05
Pay. Date : 2021-01-20
DMF Number : 25978
Submission : 2012-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-04-10
DMF Number : 29124
Submission : 2015-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2015-06-09
DMF Number : 26388
Submission : 2012-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 23183
Submission : 2009-10-16
Status : Active
Type : II
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