01 1ACIC Europe API & Pharmaceuticals
02 1Dipharma
03 1F. Hoffmann-La Roche
04 2Industriale Chimica
05 1Mankind Pharma
06 1R L Fine Chem
07 1Siegfried AG
08 1Sifavitor srl
09 1Sun Pharmaceutical Industries Limited
10 1Teva API
11 1Vasudha Pharma Chem
12 2Blank
01 3AMITRIPTYLINE HCL
02 1AMITRIPTYLINE HCL B.P. 88/USP
03 1AMITRIPTYLINE HCL USP DRUG SUBSTANCE
04 3AMITRIPTYLINE HYDROCHLORIDE
05 4AMITRIPTYLINE HYDROCHLORIDE USP
06 1AMITRYPTILINE HCL
07 1PROCEDURES FOR
01 1Cyprus
02 4India
03 1Israel
04 4Italy
05 2Switzerland
06 2Blank
01 7Active
02 7Inactive
01 4Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2908
Submission : 1977-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2413
Submission : 1975-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2535
Submission : 1975-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-16
Pay. Date : 2019-07-15
DMF Number : 33565
Submission : 2019-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-22
Pay. Date : 2016-09-26
DMF Number : 18111
Submission : 2005-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3008
Submission : 1977-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2598
Submission : 1976-01-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19589
Submission : 2006-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-03-02
DMF Number : 2719
Submission : 1976-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-21
DMF Number : 19635
Submission : 2006-07-28
Status : Active
Type : II
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