01 1Ajinomoto Company
02 3Asence Pharma
03 5Bristol Myers Squibb
04 1Gilead Sciences
05 1North China Pharmaceutical Huasheng Co Ltd
06 1Pfizer Inc
07 1Xellia Pharmaceuticals ApS
01 1AMBISOME, LIPOSOMAL AMPHOTERICIN B
02 5AMPHOTERICIN B
03 1AMPHOTERICIN B USP NON-STERILE BULK DRUG
04 1AMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS]
05 1AMPHOTERICIN B USP [ORAL GRADE]
06 1AMPHOTERICIN NON PARENTAL GRADE
07 1CRUDE AMPHOTERICIN SLURRY
08 1FUNGILIN (AMPHOTERICIN B) ORAL SUSPENSION
09 1MANUFACTURE AND CONTROLS (AMPHOTERICIN B, METHYL ESTER)
01 1China
02 1Denmark
03 3India
04 1Japan
05 7U.S.A
01 5Active
02 8Inactive
01 2Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13224
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26375
Submission : 2012-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26184
Submission : 2012-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10126
Submission : 1987-06-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7514
Submission : 1988-06-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2578
Submission : 1975-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9564
Submission : 1992-03-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-16
Pay. Date : 2021-09-29
DMF Number : 18157
Submission : 2005-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13544
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-13
Pay. Date : 2012-11-19
DMF Number : 13682
Submission : 1998-09-01
Status : Active
Type : II
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