Mayne Pharma I N T Pty L T D

FDA Filings

This page includes the latest FDA filings for Mayne Pharma I N T Pty L T D. 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
079f5bf1-4d13-4060-af88-f2301dde0ba1	Prescription Medication	2025-11-08
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2025-06-26
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2025-05-11
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2025-04-25
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2025-04-18
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2025-04-17
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2025-04-10
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2025-04-10
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2025-04-10
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2025-04-10
Carbidopa and Levodopa Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2025-04-02
Carbidopa and Levodopa Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-12-10
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-11-21
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-08-24
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-08-22
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-08-22
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2024-04-27
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2024-03-02
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2023-12-08
Carbidopa and Levodopa Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2023-07-07
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2023-07-07
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2023-06-10
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2023-06-09
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2023-06-09
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2023-05-31
Diltiazem Hydrochloride Extended-Release Mayne Pharma, Mayne Pharma Int. Pty. Ltd., Catalent Greenville, Inc.	Prescription Medication	2023-01-30
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2023-01-02
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2022-12-30
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2022-12-21
BUDESONIDE (ENTERIC COATED) Mayne Pharma Inc., Mayne Pharma International Pty Ltd, Mayne Pharma Inc	Prescription Medication	2022-12-13
erythromycin Mayne Pharma Inc., Mayne Pharma International Pty Ltd	Prescription Medication	2022-12-09
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2022-10-14
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2022-10-14
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2022-10-09
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2022-05-26
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2021-12-01
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2021-06-30
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2021-06-26
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2021-06-26
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2021-05-27
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2021-02-05
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2020-10-16
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2020-10-02
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2020-10-02
NDC 50546-194 Mayne Pharma International Pty Ltd		2020-10-01
Topical Anti-Fungal Solution Wintermute Biomedical, Inc., Wintermute Biomedical, Inc, Mayne Pharma International Pty Ltd	Otc Medication	2020-08-31
Carbidopa and Levodopa Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2020-08-18
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2020-08-06
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2020-06-04
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2020-05-01
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2020-05-01
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2020-04-25
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2020-02-08
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2020-01-03
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2019-11-16
BUDESONIDE (ENTERIC COATED) Mayne Pharma Inc., Mayne Pharma International Pty Ltd, Mayne Pharma Inc	Prescription Medication	2019-10-31
Clofarabine Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation	Prescription Medication	2019-10-25
erythromycin Mayne Pharma Inc., Mayne Pharma International Pty Ltd	Prescription Medication	2019-10-05
Tolsura Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2019-09-14
NDC 50546-401 Mayne Pharma International Pty Ltd		2019-09-05
NDC 50546-399 Mayne Pharma International Pty Ltd		2019-09-05
NDC 50546-092 Mayne Pharma International Pty Ltd		2019-07-31
NDC 50546-091 Mayne Pharma International Pty Ltd		2019-07-31
NDC 50546-580 Mayne Pharma International Pty Ltd		2019-05-20
Intuniv Takeda Pharmaceuticals America, Inc., Industriale Chimica SRL, Catalent Pharma Solutions, LLC, Mayne Pharma International Pty Ltd., Patheon Manufacturing Services LLC, Quimica Sintetica S.A.	Prescription Medication	2019-05-18
NDC 50546-462 Mayne Pharma International Pty Ltd		2018-10-26
Carbidopa and Levodopa Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2018-10-23
DORYX MPC Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc., Carton Service, Incorporated	Prescription Medication	2018-08-07
Doxycycline Hyclate Mayne Pharma, Mayne Pharma International Pty Ltd, Mayne Pharma Inc.	Prescription Medication	2018-07-30
Doxycycline Hyclate Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2018-07-30
Doryx Mayne Pharma Commercial LLC, Mayne Pharma International Pty Ltd, Catalent Greenville, Inc.	Prescription Medication	2018-07-30
NDC 50546-858 Mayne Pharma International Pty Ltd		2018-03-09
NDC 50546-856 Mayne Pharma International Pty Ltd		2018-03-09
NDC 50546-077 Mayne Pharma International Pty Ltd		2018-03-09
NDC 50546-250 Mayne Pharma International Pty Ltd		2017-02-15
NDC 50546-775 Mayne Pharma International Pty Ltd		2016-09-09
NDC 50546-716 Mayne Pharma International Pty Ltd		2016-09-09
NDC 50546-715 Mayne Pharma International Pty Ltd		2016-09-09
NDC 50546-710 Mayne Pharma International Pty Ltd		2016-09-09
NDC 50546-559 Mayne Pharma International Pty Ltd		2016-09-09
NDC 50546-719 Mayne Pharma International Pty Ltd		2015-04-13
NDC 50546-300 Mayne Pharma International Pty Ltd		1981-01-26

Similar & Related FDA Registered Companies

• Takeda Pharmaceuticals America, Inc.
• Industriale Chimica SRL
• Catalent Pharma Solutions, LLC
• Patheon Manufacturing Services LLC
• Quimica Sintetica S.A.
• Mayne Pharma Commercial LLC
• Catalent Greenville, Inc.
• Mayne Pharma
• Mayne Pharma Inc.
• Carton Service, Incorporated
• Winthrop U.S, a business of sanofi-aventis U.S. LLC
• Pharmachemie B.V.
• Pfanstiehl, Inc.
• Ash Stevens Inc.
• EUROAPI UK LIMITED
• Genzyme Corporation
• Wintermute Biomedical, Inc.

Related Finance Registrations

SEC

0001611534

Mayne Pharma International Pty Ltd of AUSTRALIA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202006264221	Tauranga,New Zealand -> Philadelphia, Pennsylvania	ERYC 333MG CAPSULES CANADA 100'S LOADED ON 3 PALLETS	91 CTN
202006246377	Tauranga,New Zealand -> Philadelphia, Pennsylvania	ERYC 333MG CAPSULES CANADA 100'S LOADED ON 3 PALLETS	91 CTN
201804061716	Singapore,Singapore -> Norfolk, Virginia	PHARMA	15 DRM