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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2013-11-18
DMF Number : 18364
Submission : 2005-05-16
Status : Active
Type : II
Date of Issue : 2020-01-31
Valid Till : 2022-07-02
Written Confirmation Number : WC-0132
Address of the Firm :
NDC Package Code : 55363-254
Start Marketing Date : 2012-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : Reviewed
Rev. Date : 2014-03-06
Pay. Date : 2014-02-25
DMF Number : 5882
Submission : 1985-06-27
Status : Active
Type : II
Registration Number : 220MF10257
Registrant's Address : Str. Aleeea Uzinei Nr. 11, 505700 Victoria, Judetul Brasov, Romania
Initial Date of Registration : 2008-12-12
Latest Date of Registration : --
NDC Package Code : 68444-0002
Start Marketing Date : 2010-10-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (90kg/90kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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DMF Number : 37190
Submission : 2022-06-17
Status : Active
Type : IV
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DMF Number : 26196
Submission : 2012-07-03
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Date of Issue : 2016-03-04
Valid Till : 2019-03-03
Written Confirmation Number : WC-0352
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Registration Number : 223MF10012
Registrant's Address : Str. Aleeea Uzinei Nr. 11, 505700 Victoria, Judetul Brasov, Romania
Initial Date of Registration : 2011-01-21
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NDC Package Code : 68444-0002
Start Marketing Date : 2010-10-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (90kg/90kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Date of Issue : 2020-01-31
Valid Till : 2022-07-02
Written Confirmation Number : WC-0132A1
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NDC Package Code : 55363-254
Start Marketing Date : 2012-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Registration Number : 229MF10095
Registrant's Address : Str. Aleeea Uzinei Nr. 11, 505700 Victoria, Judetul Brasov, Romania
Initial Date of Registration : 2017-05-16
Latest Date of Registration : --
NDC Package Code : 68444-0002
Start Marketing Date : 2010-10-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (90kg/90kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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