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01 1ISOETHARINE HCl USP & NUMOTAC TABLETS WITH ISOETHARINE HCl
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1984
Submission : 1972-08-11
Status : Inactive
Type : II
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A Isoetharine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoetharine HCl, including repackagers and relabelers. The FDA regulates Isoetharine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoetharine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Isoetharine HCl supplier is an individual or a company that provides Isoetharine HCl active pharmaceutical ingredient (API) or Isoetharine HCl finished formulations upon request. The Isoetharine HCl suppliers may include Isoetharine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Isoetharine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoetharine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoetharine HCl active pharmaceutical ingredient (API) in detail. Different forms of Isoetharine HCl DMFs exist exist since differing nations have different regulations, such as Isoetharine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoetharine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Isoetharine HCl USDMF includes data on Isoetharine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoetharine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoetharine HCl suppliers with USDMF on PharmaCompass.
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