Axplora- The partner of choice for complex APIs.
01 2Axplora
02 1DEAFARMA
03 2SIMS Srl
04 2Teva API
05 1Teva Pharmaceutical Industries
06 1Unipex
07 1Blank
01 1France
02 2Germany
03 3Israel
04 3Italy
05 1Blank
01 4Active
02 3Inactive
03 3Blank
01 10Blank
01 10Blank
01 10Blank
Axplora- The partner of choice for complex APIs.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 19477
Submission : 2006-05-31
Status : Active
Type : II
NDC Package Code : 46439-8715
Start Marketing Date : 2010-04-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU |
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-02
Pay. Date : 2014-05-27
DMF Number : 26148
Submission : 2012-06-12
Status : Active
Type : II
NDC Package Code : 46439-8715
Start Marketing Date : 2010-04-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-07
Pay. Date : 2013-04-10
DMF Number : 11574
Submission : 1995-07-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-10
Pay. Date : 2012-11-08
DMF Number : 22772
Submission : 2009-05-13
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8459
Submission : 1990-02-27
Status : Inactive
Type : II
Portfolio PDF
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4774
Submission : 1982-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6811
Submission : 1987-01-23
Status : Inactive
Type : II
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