Department of Health

Food and Drug Administration

APPLICATION FORM 5 SOURCES & CLIENTS

Document Tracking Number APPLICATION FORM STATUS

GENERAL INFORMATION:
ESTABLISHMENT INFORMATION:
Description (Optional): PRODUCT INFORMATION:
SUPPORTING INFORMATION:
1 GENERAL INFORMATION SOURCES & CLIENTS:
APPLICANT INFORMATION:
1.1 Product Center:

This form was last edited on 13 October 2016, 10:28 AM.

Page 1 Integrated Application Form (97-2003 Compatible) (3) 19/06/2019 3:00 PM

 Provide in this space a description of the
product in terms of rheology, thermal, and
Off-white to beige, semi biconvex film- Use this space to explain how the lot code
geometry properties among others, as
CLOPIDOGREL (as BISULFATE) coated tablet with score on one side and used on the product label is correctly
applicable; Indicate if appropriate
plain on the other side interpreted
microbiological cultures present in the
product
CLOPIDOGREL (AS BISULFATE)
2) Active Pharmaceutical Ingredient;
3) Active Pharmaceutical Ingredient;
4) Active Pharmaceutical Ingredient;
5) Active Pharmaceutical Ingredient;
6) Active Pharmaceutical Ingredient;
7) Active Pharmaceutical Ingredient;
8) Active Pharmaceutical Ingredient;
9) Active Pharmaceutical Ingredient;
10) Active Pharmaceutical Ingredient;
11) Active Pharmaceutical Ingredient;
12) Active Pharmaceutical Ingredient;
NINBO BEITONG IMP. & EXP. CO. LTD., INDIA
2) API Manufacturer, Address Address Address;
3) API Manufacturer, Address Address Address;
4) API Manufacturer, Address Address Address;
5) API Manufacturer, Address Address Address;
6) API Manufacturer, Address Address Address;
7) API Manufacturer, Address Address Address;
8) API Manufacturer, Address Address Address;
9) API Manufacturer, Address Address Address;
10) API Manufacturer, Address Address Address;
11) API Manufacturer, Address Address Address;
12) API Manufacturer, Address Address Address;
KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
2) API Supplier, Address Address Address;
3) API Supplier, Address Address Address;
4) API Supplier, Address Address Address;
5) API Supplier, Address Address Address;
6) API Supplier, Address Address Address;
7) API Supplier, Address Address Address;
8) API Supplier, Address Address Address;
9) API Supplier, Address Address Address;
10) API Supplier, Address Address Address;
11) API Supplier, Address Address Address;
12) API Supplier, Address Address Address;