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02 2Symbiotec Pharmalab
03 1Gedeon Richter
01 1Hungary
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03 1Netherlands
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-14
Pay. Date : 2016-09-02
DMF Number : 7366
Submission : 1988-03-04
Status : Active
Type : II
NDC Package Code : 60870-0203
Start Marketing Date : 1980-04-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0031
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0031
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1895
Submission : 1986-07-11
Status : Inactive
Type : II
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