01 1Derivados Quimicos SAU
02 2F. Hoffmann-La Roche
03 1Gedeon Richter
04 1Quimica Sintetica
01 4BUTOCONAZOLE NITRATE
02 1BUTOCONAZOLE NITRATE 2% VAGINAL CREAM
01 1Hungary
02 2Spain
03 2Switzerland
01 1Active
02 4Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18981
Submission : 2005-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9585
Submission : 1992-03-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3351
Submission : 1978-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15929
Submission : 2002-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13106
Submission : 1998-07-06
Status : Inactive
Type : II
A Butoconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butoconazole Nitrate, including repackagers and relabelers. The FDA regulates Butoconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butoconazole Nitrate 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 Butoconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butoconazole Nitrate supplier is an individual or a company that provides Butoconazole Nitrate active pharmaceutical ingredient (API) or Butoconazole Nitrate finished formulations upon request. The Butoconazole Nitrate suppliers may include Butoconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Butoconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butoconazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Butoconazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Butoconazole Nitrate DMFs exist exist since differing nations have different regulations, such as Butoconazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butoconazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Butoconazole Nitrate USDMF includes data on Butoconazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butoconazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butoconazole Nitrate suppliers with USDMF on PharmaCompass.
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