GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28712
Submission : 2014-10-03
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
Drug : PRED FORTE
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 17011
Country : US
Patented : No
Drug : FML
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 16851
Country : US
Patented : No
Drug : ACULAR LS
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Application Number : 21528
Country : US
Patented : Yes
Drug : PRED MILD
Dosage Form : SUSPENSION/DROPS; OPHTHALMIC
Application Number : 17100
Country : US
Patented : No
Drug : TAZORAC
Dosage Form : CREAM; TOPICAL
Application Number : 21184
Country : US
Patented : No
Drug : ESTRACE
Dosage Form : CREAM; VAGINAL
Application Number : 86069
Country : US
Patented : No
Drug : BETAGAN
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Application Number : 19814
Country : US
Patented : No
Drug : BLEPH-30
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Application Number : 80028
Country : US
Patented : No
Drug : OCUFEN
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Application Number : 19404
Country : US
Patented : No
Drug : BLEPH-10
Dosage Form : SOLUTION/DROPS; OPHTHALMIC
Application Number : 80028
Country : US
Patented : No
EXCIPIENTS BY APPLICATIONS
Application : Parenteral
Excipient Details : Used as a chelating agent in cell culture media, downstream and as a chelator stabilizer in Biopharmaceutical formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised pa...
Ingredient(s) : Disodium Edetate Excipient