01 2Johnson & Johnson Innovative Medicine
01 1OXATOMIDE TABLETS 30 MG
02 1OXATOMIDE-R 35443 AS PROCESSED IN THE BELGIUM FACILITY
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5108
Submission : 1983-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5432
Submission : 1984-06-14
Status : Inactive
Type : II
A Oxatomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxatomide, including repackagers and relabelers. The FDA regulates Oxatomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxatomide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Oxatomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxatomide supplier is an individual or a company that provides Oxatomide active pharmaceutical ingredient (API) or Oxatomide finished formulations upon request. The Oxatomide suppliers may include Oxatomide API manufacturers, exporters, distributors and traders.
click here to find a list of Oxatomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxatomide DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxatomide active pharmaceutical ingredient (API) in detail. Different forms of Oxatomide DMFs exist exist since differing nations have different regulations, such as Oxatomide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxatomide DMF submitted to regulatory agencies in the US is known as a USDMF. Oxatomide USDMF includes data on Oxatomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxatomide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxatomide suppliers with USDMF on PharmaCompass.
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