01 2Air Liquide Group
02 1CAREFUSION CORPORATION
03 1INO THERAPEUTICS INC
04 2Blank
01 12200 PPM NITRIC OXIDE/BALANCE NITROGEN GAS MIXTURE
02 1NITRIC OXIDE
03 1NITRIC OXIDE FOR INHALATION, 800PPM
04 1NITRIC OXIDE IN NITROGEN GAS MIXTURE
05 1NITRIC OXIDE IN NITROGEN GAS MIXTURE PRODUCED IN OAK BROOK, ILLINOIS
06 1VIANOX-H (NITRIC OXIDE)
01 2France
02 2U.S.A
03 2Blank
01 1Active
02 5Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24763
Submission : 2011-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11610
Submission : 1995-07-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15551
Submission : 2001-07-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17472
Submission : 2004-06-16
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11399
Submission : 1995-03-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10510
Submission : 1993-09-27
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Nitric Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitric Oxide, including repackagers and relabelers. The FDA regulates Nitric Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitric Oxide 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 Nitric Oxide supplier is an individual or a company that provides Nitric Oxide active pharmaceutical ingredient (API) or Nitric Oxide finished formulations upon request. The Nitric Oxide suppliers may include Nitric Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Nitric Oxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitric Oxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitric Oxide active pharmaceutical ingredient (API) in detail. Different forms of Nitric Oxide DMFs exist exist since differing nations have different regulations, such as Nitric Oxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitric Oxide DMF submitted to regulatory agencies in the US is known as a USDMF. Nitric Oxide USDMF includes data on Nitric Oxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitric Oxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitric Oxide suppliers with USDMF on PharmaCompass.
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