01 1Formosa Laboratories
02 1Patheon
03 1Solara Active Pharma Sciences
01 1India
02 1Taiwan
03 1U.S.A
01 2Active
02 1Blank
01 3Blank
01 1305MF10083
02 2Blank
01 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-16
Pay. Date : 2019-07-25
DMF Number : 32966
Submission : 2019-06-06
Status : Active
Type : II
NDC Package Code : 66499-0063
Start Marketing Date : 2018-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-15
Pay. Date : 2019-04-23
DMF Number : 33634
Submission : 2019-03-29
Status : Active
Type : II
NDC Package Code : 72643-016
Start Marketing Date : 2019-04-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 305MF10083
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2023-07-19
Latest Date of Registration : --
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