01 1Bausch Health
01 1MOGADON (NITRAZEPAM) TABLETS
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13151
Submission : 1998-08-24
Status : Inactive
Type : II
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A Radedorm manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Radedorm, including repackagers and relabelers. The FDA regulates Radedorm manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Radedorm 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 Radedorm manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Radedorm supplier is an individual or a company that provides Radedorm active pharmaceutical ingredient (API) or Radedorm finished formulations upon request. The Radedorm suppliers may include Radedorm API manufacturers, exporters, distributors and traders.
click here to find a list of Radedorm suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Radedorm DMF (Drug Master File) is a document detailing the whole manufacturing process of Radedorm active pharmaceutical ingredient (API) in detail. Different forms of Radedorm DMFs exist exist since differing nations have different regulations, such as Radedorm USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Radedorm DMF submitted to regulatory agencies in the US is known as a USDMF. Radedorm USDMF includes data on Radedorm's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Radedorm USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Radedorm suppliers with USDMF on PharmaCompass.
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