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