01 9Anhydrous Lactose
02 1Croscarmellose Sodium
03 1Lactose
04 3Lactose Monohydrate API
05 1Microcrystalline Cellulose
06 1Sodium Starch Glycolate
01 15Active
02 1Inactive
01 16Blank
01 16Blank
01 16Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
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DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 14644
Submission : 1999-12-23
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 15916
Submission : 2002-03-29
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 16284
Submission : 2002-12-02
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 16285
Submission : 2002-12-02
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 18730
Submission : 2005-09-06
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 15917
Submission : 2002-03-29
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 17576
Submission : 2004-07-30
Status : Active
Type : IV
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DMF Number : 17577
Submission : 2004-07-30
Status : Active
Type : IV
