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01 1Ami Lifesciences Private Limited
02 1HONOUR LAB LTD
03 1Indoco Remedies Limited
04 1Olon S.p.A
05 1Blank
01 4DICYCLOMINE HYDROCHLORIDE
02 1DICYCLOMINE HYDROCHLORIDE USP
01 3India
02 1Italy
03 1Blank
01 4Active
02 1Inactive
01 3Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40078
Submission : 2024-09-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-10
Pay. Date : 2022-03-25
DMF Number : 36977
Submission : 2022-04-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-17
Pay. Date : 2013-12-19
DMF Number : 22295
Submission : 2008-12-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-11-29
DMF Number : 2303
Submission : 1974-07-11
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9458
Submission : 1991-12-13
Status : Inactive
Type : II
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