Glaxosmithkline

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2023-12-07
Nicorette White Mint nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2023-07-21
EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine Lil' Drug Store Products, Inc.	Otc Medication	2023-07-21
Nicorette Fruit Chill nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2023-07-21
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2023-07-19
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2023-01-17
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2022-08-19
Nicorette White Mint nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2022-08-18
EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine Lil' Drug Store Products, Inc.	Otc Medication	2022-08-18
Nicorette Fruit Chill nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2022-08-18
Nicorette White Mint nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2021-12-29
EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine Lil' Drug Store Products, Inc.	Otc Medication	2021-12-29
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2021-12-29
Nicorette Fruit Chill nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2021-12-29
Haldol Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., GlaxoSmithKline	Prescription Medication	2021-08-03
761174 BLA GLAXOSMITHKLINE		2021-04-27 21:12:49
Zovirax Bausch Health Americas, Inc., GlaxoSmithKline, Bausch Health Companies Inc.	Prescription Medication	2021-01-12
Haldol Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., GlaxoSmithKline	Prescription Medication	2020-12-03
Nicorette White Mint nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2020-11-17
EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine Lil' Drug Store Products, Inc.	Otc Medication	2020-11-17
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2020-11-17
Nicorette Fruit Chill nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2020-11-17
Haldol Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., GlaxoSmithKline	Prescription Medication	2020-09-19
761158 BLA GLAXOSMITHKLINE		2020-08-11 22:10:32
Haldol Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., GlaxoSmithKline	Prescription Medication	2020-06-09
Doxorubicin Hydrochloride liposome Janssen Products, LP, Meiji Seika Pharma Co., Ltd., TTY Biopharm Company Limited, GlaxoSmithKline, Janssen Pharmaceutica NV	Prescription Medication	2020-01-08
Zovirax Bausch Health Americas, Inc., GlaxoSmithKline, Bausch Health Companies Inc.	Prescription Medication	2019-11-20
Zovirax Bausch Health Americas, Inc., GlaxoSmithKline, Bausch Health Companies Inc.	Prescription Medication	2019-11-01
Doxorubicin Hydrochloride liposome Janssen Products, LP, Meiji Seika Pharma Co., Ltd., TTY Biopharm Company Limited, GlaxoSmithKline, Janssen Pharmaceutica NV	Prescription Medication	2019-09-06
DOXIL Janssen Products, LP, Meiji Seika Pharma Co., Ltd., TTY Biopharm Company Limited (Chung-Li Factory), GlaxoSmithKline, Janssen Pharmaceutica NV	Prescription Medication	2019-08-17
Doxorubicin Hydrochloride liposome Janssen Products, LP, Meiji Seika Pharma Co., Ltd., TTY Biopharm Company Limited, GlaxoSmithKline, Janssen Pharmaceutica NV	Prescription Medication	2019-08-09
DOXIL Janssen Products, LP, Meiji Seika Pharma Co., Ltd., TTY Biopharm Company Limited (Chung-Li Factory), GlaxoSmithKline, Janssen Pharmaceutica NV	Prescription Medication	2019-08-09
Haldol Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica N.V., GlaxoSmithKline	Prescription Medication	2019-07-19
EXCEDRIN EXTRA STRENGTH PAIN RELIEVER Lil' Drug Store Products, Inc.	Otc Medication	2019-06-13
EXCEDRIN MIGRAINE acetaminophen, aspirin (nsaid) and caffeine Lil' Drug Store Products, Inc.	Otc Medication	2019-06-08
Nicorette White Mint nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2019-04-02
Nicorette Fruit Chill nicotine polacrilex Lil' Drug Store Products, Inc.	Otc Medication	2019-04-02
761122 BLA GLAXOSMITHKLINE		0000-00-00 00:00:00
210795 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
209482 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
208447 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
205625 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
203975 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
201803 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
089834 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
089833 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
089465 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
087439 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
084935 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
084060 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
083951 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
083902 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
075822 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
064033 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
064008 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
064006 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
063322 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
063295 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062755 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062736 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062727 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062691 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062690 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062435 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062321 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062273 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062270 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062241 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062238 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062233 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062223 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062212 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
062036 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061999 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061866 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061859 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061806 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061336 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
061334 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
060677 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
060666 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
060254 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
060060 ANDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050746 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050703 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050672 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050658 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050646 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050605 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050591 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050590 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050579 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050497 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050461 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050460 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050459 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050298 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050176 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
050167 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
022565 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
022460 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
022345 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
022113 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021587 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021441 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021394 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021393 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021375 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021374 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021373 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021319 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021078 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021039 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021036 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021019 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021007 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00
021004 NDA GLAXOSMITHKLINE		0000-00-00 00:00:00

Similar & Related FDA Registered Companies

• GlaxoSmithKlineConsumer Healthcare
• GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
• GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
• GLAXOSMITHKLINE CONSUMER HEALTHCARE
• GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
• GlaxoSmithKline Biologicals SA
• GlaxoSmithKline Consumer Healthcare Holdings (US)
• Lil' Drug Store Products, Inc.
• Janssen Pharmaceuticals, Inc.
• Janssen Pharmaceutica N.V.
• Bausch Health Americas, Inc.
• Bausch Health Companies Inc.
• Janssen Products, LP
• Meiji Seika Pharma Co., Ltd.
• TTY Biopharm Company Limited
• TTY Biopharm Company Limited (Chung-Li Factory)

Related Finance Registrations

NCAGE Code	SBG92	GLAXOSMITHKLINE
NCAGE Code	SBC03	GLAXOSMITHKLINE
NCAGE Code	E1245	GLAXOSMITHKLINE
CAGE Code	E1245	GLAXOSMITHKLINE
CAGE Code	SBC03	GLAXOSMITHKLINE
CAGE Code	SBG92	GLAXOSMITHKLINE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019042521802	Rotterdam,Netherlands -> Norfolk, Virginia	TOTAL 40 PALLETS ALUMINA FOIL HS-CODE 760720	40 PKG
2019042431148	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	TOTAL 38 PALLETS EMPTY AEROSOL CANS HS-CODE 761290	38 PKG
2019042424494	Rotterdam,Netherlands -> Norfolk, Virginia	TOTAL 40 PALLETS ALUMINA FOIL HS-CODE 760720	40 PKG
2019042329887	Rotterdam,Netherlands -> Norfolk, Virginia	TOTAL 40 PALLETS ALUMINA FOIL HS-CODE 760720	40 PKG
2019042230246	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	TOTAL 40 PALLETS EMPTY AERSOSOL CANS HS-CODE 761290	40 PKG
2019042225825	Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia	TOTAL 38 PALLETS EMPTY AEROSOL CANS HS-CODE 761290	38 PKG
2019042050143	Le Havre,France -> Norfolk, Virginia	OF GLOBAL DESICCANT 70X50MM ON 22 PALLETS HS-CODE 38249996	506 BOX
2019042050132	Le Havre,France -> Norfolk, Virginia	OF GLOBAL DESICCANT 70X50MM ON 22 PALLETS HS-CODE 38249996	506 BOX