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01 1Atogepant
02 1Biperiden Hydrochloride
03 2Botulinum toxin type A
04 1Butorphanol Tartrate
05 1Cyclosporine
06 1Divalproex Sodium
07 1Elagolix Sodium
08 1Enflurane
09 2Erythromycin
10 1Erythromycin Ethyl Succinate
11 1Erythromycin Stearate
12 1Erythromycin Thiocyanate
13 1Foscarbidopa
14 1Foslevodopa
15 2Glecaprevir
16 1Isoflurane
17 1Lopinavir
18 1Paricalcitol
19 2Pibrentasvir
20 1Ritonavir
21 2Terazosin HCl
22 1Thyroxine
23 2Upadacitinib
24 2Venetoclax
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01 7Active
02 24Blank
01 6Valid
02 25Blank
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01 31Blank
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01 31Blank
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01 120050831-18-C-100-05
02 120060707-48-B-224-08
03 120060707-48-B-224-08(2)
04 120130503-198-I-121-02
05 12578-1-ND
06 12578-2-ND
07 1Su325-10-ND
08 1Su325-11-ND
09 1Su325-13-ND
10 1Su325-15-ND
11 1Su325-16-ND
12 1Su325-7-ND
13 1Su325-8-ND
14 1Su325-9-ND
15 17Blank
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01 10023-5027
02 10023-5028
03 10051-0040
04 10074-0598
05 10074-5503
06 162526-1737
07 162526-1912
08 162526-2325
09 168513-1054
10 168513-2320
11 168513-7155
12 20Blank
01 31Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13800
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1998-093 - Rev 07
Issue Date : 2020-10-09
Type : Chemical and TSE
Substance Number : 994
Status : Valid
NDC Package Code : 0074-5503
Start Marketing Date : 2010-05-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea
Registration Date : 2005-08-31
Registration Number : 20050831-18-C-100-05
Manufacturer Name : AbbVie Inc.
Manufacturer Address : 1401 Sheridan Road, North Chicago, IL, 60064-4000, USA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13197
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-267 - Rev 00
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 179
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-09
Pay. Date : 2013-09-25
DMF Number : 27155
Submission : 2015-11-10
Status : Active
Type : II
Certificate Number : R1-CEP 1997-001 - Rev 08
Issue Date : 2023-05-23
Type : Chemical
Substance Number : 179
Status : Valid
Certificate Number : R2-CEP 1995-038 - Rev 05
Issue Date : 2019-01-24
Type : Chemical
Substance Number : 1074
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8904
Submission : 1990-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13443
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13372
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2006-292 - Rev 00
Issue Date : 2012-09-24
Type : Chemical
Substance Number : 1673
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24315
Submission : 2010-11-30
Status : Active
Type : II
NDC Package Code : 68513-1054
Start Marketing Date : 2011-09-30
End Marketing Date : 2027-06-25
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea
Registration Date : 2013-05-03
Registration Number : 20130503-198-I-121-02
Manufacturer Name : AbbVie Ireland NL BV
Manufacturer Address : Manorhamilton Road, Sligo, Ireland
Certificate Number : R1-CEP 2012-397 - Rev 00
Issue Date : 2019-09-19
Type : Chemical
Substance Number : 2136
Status : Valid
Registrant Name : AbbVie Korea
Registration Date : 2008-06-27
Registration Number : 2578-1-ND
Manufacturer Name : AbbVie Srl
Manufacturer Address : SR 148 Pontina Km 52, Snc-Campoverde Di Aprilia-04011, Aprilia(LT), Italy