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