01 1Bayer AG
02 1CYDEX PHARMACEUTICALS INC
03 1Cerestar USA Inc
04 1Pharmatech
05 1Roquette
06 2Wacker Chemie AG
01 1France
02 3Germany
03 2U.S.A
04 1United Kingdom
01 3Active
02 3Inactive
03 1Blank
01 7Blank
01 1227MF20001
02 6Blank
01 7Blank
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GDUFA
DMF Review : N/A
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DMF Number : 9155
Submission : 1991-06-10
Status : Active
Type : IV
GDUFA
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DMF Number : 14620
Submission : 1999-12-08
Status : Active
Type : IV
GDUFA
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DMF Number : 15489
Submission : 2001-06-15
Status : Active
Type : IV
GDUFA
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DMF Number : 9403
Submission : 1991-10-21
Status : Inactive
Type : IV
GDUFA
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DMF Number : 8423
Submission : 1990-02-02
Status : Inactive
Type : II
GDUFA
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DMF Number : 7435
Submission : 1988-04-14
Status : Inactive
Type : IV
Registration Number : 227MF20001
Registrant's Address : 2033 Becker Drive, Suite 310 Lawrence, KS 66047 United States
Initial Date of Registration : 2015-08-31
Latest Date of Registration : --
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