01 1Derivados Quimicos SAU
02 2F. Hoffmann-La Roche
03 1Gedeon Richter
04 1Olon S.p.A
05 1Quimica Sintetica
01 1Hungary
02 1Italy
03 2Spain
04 2Switzerland
01 1Active
02 4Inactive
03 1Blank
01 6Blank
01 6Blank
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18981
Submission : 2005-11-29
Status : Active
Type : II
NDC Package Code : 59349-0006
Start Marketing Date : 2018-11-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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 : 9585
Submission : 1992-03-19
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.
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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.
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