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01 1ACLIDINIUM BROMIDE
02 1APREPITANT
03 1ARFORMOTEROL TARTRATE (FORM A)
04 1ARFORMOTEROL TARTRATE (FORM D)
05 1CLEVIDIPINE BUTYRATE
06 1FORMOTEROL FUMARATE
07 1GLYCOPYRROLATE
08 1GRANISETRON BASE
09 1GRANISETRON HYDROCHLORIDE
10 1INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)
11 1LATANOPROST
12 1OLANZAPINE
13 1OLODATEROL HYDROCHLORIDE
14 1ONDANSETRON BASE
15 1ONDANSETRON HYDROCHLORIDE
16 1REVEFENACIN TRIHYDRATE
17 1RISPERIDONE
18 1SALMETEROL XINAFOATE
19 1TETRABENAZINE
20 1TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)
21 1TRAVOPROST
22 1UMECLIDINIUM BROMIDE
23 1VILANTEROL TRIFENATATE
24 1ZOLMITRIPTAN
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01 2GENTEC SA
02 22INKE SA
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01 24Spain
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01 24Active
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01 20Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-14
Pay. Date : 2023-04-21
DMF Number : 36437
Submission : 2023-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-31
Pay. Date : 2022-05-16
DMF Number : 35497
Submission : 2022-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-14
Pay. Date : 2022-03-17
DMF Number : 36435
Submission : 2022-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-07-17
DMF Number : 32990
Submission : 2018-07-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-02
Pay. Date : 2022-03-17
DMF Number : 36436
Submission : 2022-06-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-16
Pay. Date : 2017-07-06
DMF Number : 31836
Submission : 2017-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21790
Submission : 2008-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-10
Pay. Date : 2021-12-07
DMF Number : 17346
Submission : 2004-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-29
Pay. Date : 2024-12-09
DMF Number : 34411
Submission : 2024-06-25
Status : Active
Type : II
Inke S.a is a supplier offers 51 products (APIs, Excipients or Intermediates).
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