Creon
Pancrelipase
AbbVie
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002807401 | 3002807401 | AbbVie Deutschland GmbH & Co.KG | 1 | N | 2026-01-01 | Knollstrasse Ludwigshafen Rhineland-Palatinate DE 67061 |
| 3010757606 | 3010757606 | AbbVie Inc | 1 | N | 2026-01-01 | 1 N Waukegan Rd North Chicago IL US 60064 |
| 3011299837 | 3009751352 | AbbVie US LLC | 1 | Y | 2026-01-01 | 1 N Waukegan Rd North Chicago IL US 60064 |
| 3012441529 | 3012441529 | AbbVie Ireland NL B.V. Ballytivnan | 1 | N | 2026-01-01 | Ballytivnan Sligo IE N/A |
| 3013307971 | 3013307971 | ABBVIE Logistics BV, Inc | 1 | N | 2026-01-01 | Zuiderzeelaan 53 Zwolle Overijssel NL 8017 JV |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 167405 | 1533216337 | K142816 | AbbVie J | KNT | 2015-01-14 |
| 187623 | 1533216337 | K142816 | AbbVie J | KNT | 2015-01-14 |
| 179783 | 1533216337 | K142816 | AbbVie J | KNT | 2015-01-14 |
| 167405 | 1063894060 | K142793 | AbbVie PEG | KNT | 2015-01-14 |
| 187623 | 1063894060 | K142793 | AbbVie PEG | KNT | 2015-01-14 |
| 179783 | 1063894060 | K142793 | AbbVie PEG | KNT | 2015-01-14 |
| 179783 | 1455259871 | K142792 | AbbVie NJ | KNT | 2015-01-14 |
| 167405 | 1455259871 | K142792 | AbbVie NJ | KNT | 2015-01-14 |
| 338407 | 2049051054 | K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | OXK | 2013-04-17 |
| 187623 | 1202768577 | ||||
| 187623 | 1376389427 | ||||
| 187623 | 1455259871 | ||||
| 179783 | 1681490062 | ||||
| 167405 | 1681490062 | ||||
| 187623 | 1745214506 | ||||
| 187623 | 1782521715 | ||||
| 309233 | 1782521715 | ||||
| 338407 | 1982256655 | ||||
| 309233 | 1988124074 |
Product Codes Associated With Registrations#
NDC#
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Creon
Pancrelipase
Orilissa
Elagolix
Orilissa
Elagolix
Humira
Adalimumab
Humira
Adalimumab
Vyalev
foscarbidopa/foslevodopa
Kaletra
Lopinavir and Ritonavir
Humira
Adalimumab
Venclexta
Venetoclax
Venclexta
Venetoclax
Venclexta
Venetoclax
Venclexta
Venetoclax
Humira
Adalimumab
Humira
Adalimumab
Oriahnn
Elagolix and Estradiol and Norethisterone
Survanta
Beractant
Rinvoq
Upadacitinib
EMRELIS
Telisotuzumab Vedotin
Skyrizi
risankizumab-rzaa
EMRELIS
Telisotuzumab Vedotin
Skyrizi
Risankizumab-rzaa
Skyrizi
Risankizumab-rzaa
Humira
Adalimumab
Zemplar
Paricalcitol
Skyrizi
risankizumab-rzaa
Lupron Depot-PED
leuprolide acetate
Lupron Depot-PED
leuprolide acetate
Rinvoq
Upadacitinib
Rinvoq
Upadacitinib
Rinvoq
Upadacitinib
Norvir
Ritonavir
PMN#
AbbVie J
ABBVIE INC.
AbbVie PEG
AbbVie Inc.
AbbVie NJ
ABBVIE INC.
ABBVIE NJ
ABBVIE INC.
ABBVIE PEG
ABBVIE INC.
ABB VIE J
ABBVIE INC.
Applications#
GUDID#
Skyrizi - The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg/1.2mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
2022-12-07
Skyrizi - The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
2022-07-07
AbbVie Lightweight Vest XS - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Lightweight Vest S - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Lightweight Vest M - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Lightweight Vest L - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Lightweight Vest XL - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Lightweight Vest XXL - The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use only.
2021-10-19
AbbVie Hip Pack - The Hip Pack is designed to carry a CADD-Legacy® 1400 pump. This Hip Pack is intended for single-patient use only. The Hip Pack is intended to be worn around the waist.
2021-10-18
AbbVie Snug Vest XXL - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Snug Vest XL - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Snug Vest L - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Snug Vest M - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Snug Vest S - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Snug Vest XS - The Snug Vest is designed to carry a CADD-Legacy® 1400 pump. This Snug Vest is intended for single-patient use only. The Snug Vest is intended to be an undergarment layer that holds the pump close to the body. The Snug Vest features a central zipper that rises midway up the torso for tube access.
2021-10-18
AbbVie Chest Pack - The Chest Pack is designed to carry a CADD-Legacy® 1400 pump. This Chest Pack is intended for single-patient use only. The Chest Pack is intended to be put on over the head and fastened around the chest.
2021-10-18
AbbVie Cross Body Pack - The Cross Body Pack is designed to carry a CADD-Legacy® 1400 pump. This Cross Body Pack is intended for single-patient use only. The Cross Body Pack should be worn over the shoulder and positioned at or near the waist using the Belt for support.
2021-10-18
Abbvie Fitted Vest XXXL - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-20
Abbvie Fitted Vest XXXS - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso
2021-09-20
Abbvie Fitted Vest XXS - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-17
Abbvie Fitted Vest XS - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-17
Abbvie Fitted Vest Small - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-17
Abbvie Fitted Vest XL - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-17
Abbvie Fitted Vest XXL - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-17
Abbvie Fitted Vest Medium - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-14
Abbvie Fitted Vest Large - The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.
2021-09-14
Abbvie fitted belt - The AbbVie Fitted Belt is an accessory to the Duopa/Duodopa system and designed to carry a CADD-Legacy® 1400 pump and drug filled cassette. It is a sewn fabric pouch with buckled waist belt that can be worn by the patient.
2021-09-07
Fixation Plate for AbbVie PEG 15 FR - The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit
2019-04-15
AbbVie PEG - The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp
2019-04-15
AbbVie PEG - The AbbVie PEG is a percutaneous endoscopic gastrostomy (PEG, or gastric) tube, either 15 FR or 20 FR and 35 cm in length. The kit includes the following (Fig. 1): - AbbVie PEG Tube (polyurethane) - Reel of Thread with double thread and Introducer Device - Puncture Cannula with safety (air) valve - Disposable Scalpel - Silicone external Fixation Plate (radio-opaque) with integrated Tube Clip (blue of AbbVie PEG 15 FR, violet for AbbVie PEG 20 FR) - Tube Clamp
2019-04-15
Fixation Plate for AbbVie PEG 20 FR - The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit
2019-04-15
AbbVie J - The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001) AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001) This kit includes (Fig. 1): - AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock - Y-Connector for the 15 FR PEG or 20 FR PEG - Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring - Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector
2019-04-15
AbbVie Click Adaptor - The saleable unit (device count) is 1, there are 15 click adaptors in the saleable unit
2019-04-15
Y-Connector for AbbVie PEG 15 FR - The saleable unit (device count) is 1, there are 5 Y-Connectors in the saleable unit
2019-04-15
AbbVie J - The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001) AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001) This kit includes (Fig. 1): - AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock - Y-Connector for the 15 FR PEG or 20 FR PEG - Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring - Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector
2019-04-15
Y-Connector for AbbVie PEG 20 FR - The saleable unit (device count) is 1, there are 5 Y-Connectors in the saleable unit
2019-04-15
AbbVie NJ - The AbbVie NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The AbbVie NJ includes a silicone coated Stylet. The saleable unit (device count) is 1, there are 5 NJs in the saleable unit
2019-04-15