10 DEACETYL BACCATIN III USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 19260  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details 10 DEACETYL BACCATIN III (10 DAB III)    
Issue/Submission date 2006-03-14    
Atropine Sulfate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Atropine Sulfate (BP/EP/USP)    
Issue/Submission date 2016-06-15    
Atropine Sulphate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Atropine Sulphate (IP)    
Issue/Submission date 2016-06-15    
Benzethonium Chloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Benzethonium Chloride (USP)    
Issue/Submission date 2016-06-15    
Cimetropium Bromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Cimetropium Bromide (IH)    
Issue/Submission date 2016-06-15    
COLCHICINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 22564  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details COLCHICINE EXTRA PURE GRADE    
Issue/Submission date 2009-02-18    
COLCHICINE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 17003 Indian CDSCO WC-0006  
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Valid - 2019-05-27
Filling Details COLCHICINE USP Colchicine (EP/USP)    
Issue/Submission date 2003-12-01 2016-06-15    
DIGOXIN USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 27605 R0-CEP 2012-194-Rev 00 221MF10179 Indian CDSCO WC-0006  
Status DMF Status - Inactive
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
VALID   Valid - 2019-05-27
Filling Details DIGOXIN USP Digoxin Digoxin at 301, Avalon, Apartments, Mehrauli-Gurgaon Road Manglapuri, New Delhi-110 030, INDIA Digoxin (EP/USP)    
Issue/Submission date 2013-09-30 2013-05-17 2009-08-07 2016-06-15    
Digoxin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30724 221MF10179  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details DIGOXIN USP Digoxin at 301, Avalon, Apartments, Mehrauli-Gurgaon Road Manglapuri, New Delhi-110 030, INDIA    
Issue/Submission date 2016-07-06 2009-08-07    
Enoxolone USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Enoxolone (EP)    
Issue/Submission date 2016-06-15    
Homatropine methyl bromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Homatropine Methyl Bromide (USP/EP)    
Issue/Submission date 2016-06-15    
Hyoscine butylbromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Hyoscine Butylbromide (EP)    
Issue/Submission date 2016-06-15    
Hyoscyamine Hydrobromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Hyoscyamine Hydrobromide (USP)    
Issue/Submission date 2016-06-15    
Hyoscyamine sulphate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Hyoscyamine Sulphate (IP/BP/EP/USP)    
Issue/Submission date 2016-06-15    
METHSCOPOLAMINE BROMIDE USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 29805 Indian CDSCO WC-0006  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - Complete
  Valid - 2019-05-27
Filling Details METHSCOPOLAMINE BROMIDE USP Methscopolamine Bromide (USP)    
Issue/Submission date 2015-09-24 2016-06-15    
Nicotine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 221MF10263 Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details NICOTINE at 201, Empire Plaza, Sultanpur, Mehrauli-Gurgaon Road, New Delhi, (INDIA) -110 030 Nicotine (EP/USP)    
Issue/Submission date 2009-12-07 2016-06-15    
Nicotine polacrilex USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 221MF10263 Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details NICOTINE at 201, Empire Plaza, Sultanpur, Mehrauli-Gurgaon Road, New Delhi, (INDIA) -110 030 Nicotine Polacrilex (USP)    
Issue/Submission date 2009-12-07 2016-06-15    
Paclitaxel USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Paclitaxel (EP/USP)    
Issue/Submission date 2016-06-15    
Quinine dihydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Quinine Dihydrochloride (BP)    
Issue/Submission date 2016-06-15    
Quinine Sulphate USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Quinine Sulphate (EP/USP)    
Issue/Submission date 2016-06-15    
Reserpine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Reserpine (EP/USP)    
Issue/Submission date 2016-06-15    
Scopolamine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30687  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
 
Filling Details HYOSCINE EP (SCOPOLAMINE)    
Issue/Submission date 2016-07-06    
Scopolamine Hydrobromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Scopolamine Hydrobromide (USP)    
Issue/Submission date 2016-06-15    
Scopolamine Hydrobromide USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 30721 Indian CDSCO WC-0006  
Status DMF Status - Active
GDUFA Facility Fees - Paid
GDUFA DMF Review - N/A
  Valid - 2019-05-27
Filling Details SCOPOLAMINE HYDROBROMIDE USP Hyoscine Hydrobromide (EP)    
Issue/Submission date 2016-07-06 2016-06-15    
sennoside A and B USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number 225MF10137  
Status  
Filling Details SENNOSIDES USP at 301, Avalon, Apartments, Mehrauli-Gurgaon Road Manglapuri, New Delhi-110 030, INDIA    
Issue/Submission date 2013-07-23    
Silybin USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Silymarin extract (IH)    
Issue/Submission date 2016-06-15    
Thiocolchicoside USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Thiocolchicoside (FP/IH)    
Issue/Submission date 2016-06-15    
UNII-R7M676M8YV USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Nicotine Ditartrate Dihydrate (EP)    
Issue/Submission date 2016-06-15    
Vincamine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Vincamine (FP/IH)    
Issue/Submission date 2016-06-15    
Vinpocetine USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Vinpocetine (EP/USP)    
Issue/Submission date 2016-06-15    
Yohimbine Hydrochloride USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Yohimbine Hydrochloride (EP/USP)    
Issue/Submission date 2016-06-15    
USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Nicotine Resinate (EP)    
Issue/Submission date 2016-06-15    
USDMF CEP/COS Japan DMF Written Confirmation Documents Additional Info
Application Number Indian CDSCO WC-0006  
Status   Valid - 2019-05-27
Filling Details Centella Asiatica Triterpenes (USP)    
Issue/Submission date 2016-06-15