HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1Neuland Laboratories
03 1Apicore LLC
04 1Cilag AG
05 1Curia
06 2Enaltec Labs Private Limited
07 2Globofarm International
08 2MSN Laboratories
09 1Micro Labs Limited
01 10India
02 1Switzerland
03 1U.S.A
01 5Active
02 1Inactive
03 6Blank
01 12Blank
01 12Blank
01 1WC-0021A4
02 1WC-0021n
03 10Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-11-24
DMF Number : 28277
Submission : 2014-05-08
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-15
Pay. Date : 2016-03-24
DMF Number : 28932
Submission : 2015-02-04
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0020
Start Marketing Date : 2015-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20066
Submission : 2006-12-21
Status : Active
Type : II
NDC Package Code : 12502-5263
Start Marketing Date : 2010-01-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2012-04-20
Registration Number : 5242-3-ND
Manufacturer Name : Cilag AG
Manufacturer Address : Hochstrasse 201, 8200 Schaffhausen
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27559
Submission : 2013-12-21
Status : Inactive
Type : II
Date of Issue : 2022-01-04
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021A4
Address of the Firm :
NDC Package Code : 14501-0020
Start Marketing Date : 2015-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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