01 1CO-PROCESSED MIXTURE OF LACTOSE AND LACTITOL
02 1HMS LACTOSE DT AND PHARMATOSE® DCL 15
03 1INHALATION GRADE LACTOSE (IGL)
04 1INHALATION LACTOSE
05 1MICROCRYSTALLINE CELLULOSE (SPRAY DRIED)
06 1PHARMATOSE 200 M (DPI QUALITY)
07 1PHARMATOSE DCL 21
08 1PHARMATOSE® DCL 11
09 1PRIMELLOSE (CROSCARMELLOSE SODIUM)
10 1PRIMOJEL
11 1RESPITOSE AN001
12 1RESPITOSE ML001
13 1RESPITOSE ML002
14 1RESPITOSE SV 001 (DPI QUALITY)
15 1RESPITOSE SV003
16 1RESPITOSE(R) ML003
01 1DFE PHARMA GMBH & CO KG
02 14DFE PHARMA GMBH AND CO KG
03 1DMV INTERNATIONAL GMBH
01 16Germany
01 15Active
02 1Inactive
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 33935
Submission : 2020-08-05
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
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DMF Number : 21014
Submission : 2007-11-02
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 27249
Submission : 2013-06-04
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15917
Submission : 2002-03-29
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17577
Submission : 2004-07-30
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17576
Submission : 2004-07-30
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 9662
Submission : 1992-04-21
Status : Active
Type : IV
Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3015
Submission : 1977-08-24
Status : Active
Type : IV
Excipients Web Link
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