01 1Cadila Pharmaceuticals
02 1Cyalume Specialty Products
03 1Mallinckrodt Pharmaceuticals
04 1Siegfried AG
01 1D-PSEUDOEPHEDRINE FOR TIME RELEASE BEAD
02 1PSEUDOEPHEDRINE
03 2PSEUDOEPHEDRINE TANNATE
01 1India
02 1Ireland
03 1Switzerland
04 1U.S.A
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20819
Submission : 2007-08-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23482
Submission : 2010-01-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3620
Submission : 1979-09-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-05
Pay. Date : 2013-01-24
DMF Number : 4185
Submission : 1981-05-27
Status : Active
Type : II
91
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A Triaminic Infant Oral Decongestant Drops manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triaminic Infant Oral Decongestant Drops, including repackagers and relabelers. The FDA regulates Triaminic Infant Oral Decongestant Drops manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triaminic Infant Oral Decongestant Drops 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 Triaminic Infant Oral Decongestant Drops DMF (Drug Master File) is a document detailing the whole manufacturing process of Triaminic Infant Oral Decongestant Drops active pharmaceutical ingredient (API) in detail. Different forms of Triaminic Infant Oral Decongestant Drops DMFs exist exist since differing nations have different regulations, such as Triaminic Infant Oral Decongestant Drops USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triaminic Infant Oral Decongestant Drops DMF submitted to regulatory agencies in the US is known as a USDMF. Triaminic Infant Oral Decongestant Drops USDMF includes data on Triaminic Infant Oral Decongestant Drops's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triaminic Infant Oral Decongestant Drops USDMF is kept confidential to protect the manufacturer’s intellectual property.
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