Novo Nordisk Inc

FDA Filings

This page includes the latest FDA filings for Novo Nordisk Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Novo Nordisk Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9681821
FEI Number3002807752
NameNOVO NORDISK A/S
Owner & OperatorNOVO NORDISK INC.
Contact Address800 Scudders Mill Road
Plainsboro NJ 08536 US
Official Correspondent
  • John Signorin
  • x-609-9875967-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBRENNUM PARK
HILLEROED Region Hovedstaden, DK-3400 DK
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number2244771
FEI Number2244771
NameNOVO NORDISK INC.
Owner & OperatorNOVO NORDISK INC.
Contact Address800 Scudders Mill Road
Plainsboro NJ 08536 US
Official Correspondent
  • John Signorin
  • x-609-9875967-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address800 Scudders Mill Rd
Plainsboro, NJ 08536 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number9681822
FEI Number3004547341
NameNOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI
Owner & OperatorNOVO NORDISK INC.
Contact Address800 Scudders Mill Road
Plainsboro NJ 08536 US
Official Correspondent
  • John Signorin
  • x-609-9875967-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSTENAGER ALLE 4
HJOERRING Region Nordjylland, -- DK
Establishment TypeManufacture Medical Device



Registration Number3005186124
FEI Number3005186124
NameNovo Nordisk (China) Pharmaceuticals, Co. Ltd.
Owner & OperatorNOVO NORDISK INC.
Contact Address800 Scudders Mill Road
Plainsboro NJ 08536 US
Official Correspondent
  • John Signorin
  • x-609-9875967-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address99 Nanhai Road TEDA
Tianjin Tianjin, 300457 CN
Establishment TypeManufacture Medical Device



Registration Number3002807751
FEI Number3002807751
NameJohn Signorin
Owner & OperatorNOVO NORDISK INC.
Contact Address800 Scudders Mill Road
Plainsboro NJ 08536 US
Official Correspondent
  • John Signorin
  • x-609-9875967-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address800 Scudders Mill Rd
Plainsboro, NJ 08536 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Novo Nordisk Inc.
NovoFine Plus 32G Tip X 4 Mm2020-12-19
NOVO NORDISK INC
2020-09-01 18:51:41
NOVO NORDISK INC.
FlexPro® PenMate® 7712902019-08-16
NOVO NORDISK INC.
NovoPen Echo® 1854592019-04-03
NOVO NORDISK INC.
NovoFine® 32G Tip 1851972019-04-03
NOVO NORDISK INC.
NovoFine® 32G Tip 1851892019-04-03
Novo Nordisk (China) Pharmaceuticals, Co. Ltd. [NOVO NORDISK INC.]
NovoPen Echo2019-01-22
NOVO NORDISK INC.
NovoPen Echo2019-01-22
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoPen Echo2019-01-22
Novo Nordisk Inc.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)2018-12-17
NOVO NORDISK INC.
NovoFine 32G Tip2018-12-06
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoFine 32G Tip2018-12-06
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NovoFine 32G Tip2018-12-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1858512018-07-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1858502018-07-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1856512018-07-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1856502018-07-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1855912018-07-06
NOVO NORDISK INC.
NovoFine® Plus 32G 1855502018-07-06
NOVO NORDISK INC.
NovoTwist® 32G 1853892018-07-06
NOVO NORDISK INC.
NovoFine® Autocover® 30G 1852972018-07-06
NOVO NORDISK INC.
NovoFine® Autocover® 30G 1852752018-07-06
NOVO NORDISK INC.
Administration Set 7200062018-03-29
NOVO NORDISK INC.
NovoFine® 30G 1852502018-03-29
Novo Nordisk Inc.
NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall)2018-01-17
Novo Nordisk (China) Pharmaceuticals, Co. Ltd. [NOVO NORDISK INC.]
NovoPen Echo2016-11-02
NOVO NORDISK INC.
NovoPen Echo2016-11-02
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoPen Echo2016-11-02
Novo Nordisk Inc.
NovoPen Echo2016-10-18
NOVO NORDISK INC.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)2015-07-31
NOVO NORDISK INC.
FLEXPRO PENMATE2015-07-15
NOVO NORDISK A/S [NOVO NORDISK INC.]
FLEXPRO PENMATE2015-07-15
NOVO NORDISK INC.
NovoFine? Plus2014-05-30
NOVO NORDISK INC.
NovoFine? Plus 32G x 4 mm (1/6") Disposable Needle2014-05-30
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoFine? Plus2014-05-30
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoFine? Plus 32G x 4 mm (1/6") Disposable Needle2014-05-30
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NovoFine? Plus2014-05-30
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NovoFine? Plus 32G x 4 mm (1/6") Disposable Needle2014-05-30
NOVO NORDISK INC.
NOVOFINE PLUS 32G 4 MM2014-05-21
NOVO NORDISK INC.
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN2013-08-15
NOVO NORDISK INC.
NOVOFINE 32G Tip2013-06-13
NOVO NORDISK A/S [NOVO NORDISK INC.]
NOVOFINE 32G Tip2013-06-13
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NOVOFINE 32G Tip2013-06-13
NOVO NORDISK INC.
NovoTwist 32G Tip2010-06-23
NOVO NORDISK INC.
NovoTwist 30G2010-06-23
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoTwist 32G Tip2010-06-23
NOVO NORDISK A/S [NOVO NORDISK INC.]
NovoTwist 30G2010-06-23
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NovoTwist 32G Tip2010-06-23
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NovoTwist 30G2010-06-23
NOVO NORDISK INC.
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')2010-06-18
NOVO NORDISK INC.
FLEXPEN NEEDLE2010-02-01
NOVO NORDISK INC.
Administration Set2007-11-29
NOVO NORDISK A/S [NOVO NORDISK INC.]
Administration Set2007-11-29
John Signorin [NOVO NORDISK INC.]
Administration Set2007-11-29
NOVO NORDISK INC.
NOVOFINE AUTOCOVER 30G2006-11-27
NOVO NORDISK A/S [NOVO NORDISK INC.]
NOVOFINE AUTOCOVER 30G2006-11-27
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NOVOFINE AUTOCOVER 30G2006-11-27
NOVO NORDISK INC.
NOVOFINE 32G TIP2005-12-21
NOVO NORDISK INC.
NOVOFINE AUTOCOVER 30G X 8MM2005-03-30
NOVO NORDISK INC.
NOVOFINE 30G1996-08-08
NOVO NORDISK A/S [NOVO NORDISK INC.]
NOVOFINE 30G1996-08-08
NOVO NORDISK A/S - NEEDLE MANUFACTURING AND SOURCI [NOVO NORDISK INC.]
NOVOFINE 30G1996-08-08
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00
NOVO NORDISK INC
0000-00-00 00:00:00

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092328690Anvers,Belgium -> Norfolk, VirginiaRUBBER STOPPERS FOR PHARMACEUTICAL20 PCS
20200922124Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaRAWMATERIALS25 PKG
2020092137532Anvers,Belgium -> Norfolk, VirginiaRUBBER STOPPERS FOR PHARMACEUTICAL20 PCS
2020091241296Anvers,Belgium -> Norfolk, VirginiaRAMATERIAL FOR PHARMACEUTICALS174 PCS
2020091241296Anvers,Belgium -> Norfolk, VirginiaRAMATERIAL FOR PHARMACEUTICALS174 PCS
2020090732864Anvers,Belgium -> Norfolk, VirginiaRUBBER STOPPERS FOR PHARMACEUTICAL20 PCS
2020090114Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaINSULIN15 PKG
2020090112Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaPHARMACEUTICALS48 PKG
2020090112Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaPHARMACEUTICALS48 PKG
2020090152486Pusan,South Korea -> Los Angeles, CaliforniaNOVOPEN ECHO6 PKG

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