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