Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1Breathgreen Pharmaceuticals
04 1Melody Healthcare Pvt Ltd
01 1INDACATEROL MALEATE
02 1INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)
03 1INDACATEROL MALEATE IH
04 1INDACATEROL MALEATE(MICRONIZED AND NON-MICRONIZED)
01 2India
02 1Spain
03 1U.S.A
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34411
Submission : 2024-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34294
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39765
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38000
Submission : 2023-02-02
Status : Active
Type : II
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