Roxane Laboratories Inc

FDA Filings

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

FDA Filings

Device Company	Device	Date
Methadone Hydrochloride Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2024-03-22
Diphenoxylate Hydrochloride and Atropine Sulfate Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2023-05-02
Methadone Hydrochloride Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2023-02-09
Methadone Hydrochloride Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2021-04-18
Clotrimazole Cardinal Health	Prescription Medication	2020-05-30
Diphenoxylate Hydrochloride and Atropine Sulfate Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2020-01-27
Clotrimazole Cardinal Health	Prescription Medication	2019-07-24
Methadone Hydrochloride Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2016-09-30
Milk of Magnesia West-Ward Pharmaceuticals Corp., Roxane Laboratories, Inc., West-Ward Columbus Inc.	Otc Medication	2016-09-14
Diphenoxylate Hydrochloride and Atropine Sulfate Hikma Pharmaceuticals USA Inc., West-Ward Columbus Inc.	Prescription Medication	2016-09-13
Temozolomide Roxane Laboratories, Inc., Boehringer Ingelheim Roxane Inc	Prescription Medication	2016-04-11
NDC 0054-0325 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
NDC 0054-0324 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
NDC 0054-0323 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
NDC 0054-0322 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
NDC 0054-0321 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
NDC 0054-0320 Roxane Laboratories, Inc.	Temozolomide	2016-03-24
Oxycodone Hydrochloride Roxane Laboratories, Inc., Bohringer Ingelheim Roxane, Inc.	Prescription Medication	2015-12-04
Zolpidem Tartrate Roxane Laboratories, Inc, Boehringer Ingelheim Roxane Inc, Assia Chemical Industries Ltd. - Teva Tech Site	Prescription Medication	2015-09-24
Levetiracetam Roxane Laboratories, Inc, Boehringer Ingelheim Roxane Inc, Esteve Quimica, SA	Prescription Medication	2014-07-25
NDC 0054-0522 Roxane Laboratories, Inc.	Oxycodone Hydrochloride	2013-07-16
Morphine Sulfate H.J. Harkins Company, Inc., Roxane Laboratories, Inc, Boehringer Ingelheim Roxane Inc, Mallinckrodt Inc.	Prescription Medication	2011-12-30
NDC 0054-0224 Roxane Laboratories, Inc	Levetiracetam	2009-01-15
NDC 0054-0087 Roxane Laboratories, Inc	Zolpidem Tartrate	2007-04-27
NDC 0054-0086 Roxane Laboratories, Inc	Zolpidem Tartrate	2007-04-27
367b47d7-c4de-4b39-bd3a-69c29d80396f Roxane Laboratories, Inc.	Prescription Medication	2006-12-08
PMN K822971 ROXANE LABORATORIES, INC.	SALIVA SUBSTITUTE	1982-11-16

Similar & Related FDA Registered Companies

• Hikma Pharmaceuticals USA Inc.
• West-Ward Columbus Inc.
• Cardinal Health
• West-Ward Pharmaceuticals Corp.
• Boehringer Ingelheim Roxane Inc
• Bohringer Ingelheim Roxane, Inc.
• Assia Chemical Industries Ltd. - Teva Tech Site
• Esteve Quimica, SA
• H.J. Harkins Company, Inc.
• Mallinckrodt Inc.

Related Finance Registrations

CAGE Code	1H5R4	ROXANE LABORATORIES, INC. SUB OF BOEHRINGER INGELHEIM CORP.
DUNS	833490464	Roxane Laboratories, Inc.