ALOGLIPTIN BENZOATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Apremilast USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Aprepitant USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Aprepitant (IH)    
Issue/Submission date 2013-07-17    
AZITHROMYCIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Azithromycin (BP/EP/USP)    
Issue/Submission date 2013-07-17    
Azithromycin Dihydrate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
Bazedoxifene USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack- Available, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Beraprost USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Bisoprolol Fumarate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R0-CEP 2013-342-Rev 01 Indian CDSCO WC-0214  
Status VALID   Expired - 2016-07-02
Filling Details Bisoprolol fumarate Bisoprolol Fumarate (USP)    
Issue/Submission date 2016-02-24 2013-07-17    
Bisoprolol Hemifumarate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
brexpiprazole USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
CHLORAMPHENICOL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214 CoA - pdf  
Status   Expired - 2016-07-02
Filling Details Chloramphenicol (BP/EP/USP)    
Issue/Submission date 2013-07-17    
CHLORAMPHENICOL PALMITATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02 Tech Pack- Available - pdf
Filling Details Chloramphenicol Palmitate (BP/EP/USP)    
Issue/Submission date 2013-07-17    
Cinacalcet Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack- Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
DABIGATRAN ETEXILATE MESYLATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Product Presentation - pdf
Filling Details    
Issue/Submission date    
Dapagliflozin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
DROPERIDOL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Droperidol (BP/EP/USP)    
Issue/Submission date 2013-07-17    
Edoxaban USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Empagliflozin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
ERYTHROMYCIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number R1-CEP 2009-267-Rev 00 Indian CDSCO WC-0214  
Status VALID   Expired - 2016-07-02 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Erythromycin (BP/EP/USP)    
Issue/Submission date 2016-12-15 2013-07-17    
Erythromycin estolate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Erythromycin Estolate (BP/EP/USP)    
Issue/Submission date 2013-07-17    
erythromycin ethyl succinate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Ethyl Succinate (BP/EP/USP)    
Issue/Submission date 2013-07-17    
ERYTHROMYCIN STEARATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Erythromycin Stearate (EP/USP)    
Issue/Submission date 2013-07-17    
ESMOLOL HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Esmolol HCl (IH)    
Issue/Submission date 2013-07-17    
FLUVOXAMINE MALEATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02 Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details Fluvoxamine Maleate (BP/USP)    
Issue/Submission date 2013-07-17    
Landiolol HCL USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Landiolol HCL (IH)    
Issue/Submission date 2013-07-17    
Linagliptin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Macitentan USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Under Development- Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Mirabegron USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
PROCHLORPERAZINE MALEATE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Prochlorperazine Maleate (BP/EP/USP)    
Issue/Submission date 2013-07-17    
Rivaroxaban USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
S 20098 USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack, Mexico, Brazil DMF, KDMF, TDMF Available - pdf
Filling Details    
Issue/Submission date    
S 20098 USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number  
Status   Tech Pack- Available, Mexico, Brazil DMF, KDMF, TDMF Available in 2016 - pdf
Filling Details    
Issue/Submission date    
Treprostinil USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0214  
Status   Expired - 2016-07-02
Filling Details Treprostinil Monohydrate (M-5 Monohydrate)    
Issue/Submission date 2013-07-17