Dear Sir,

We would like to file ANDA application for one of our ophthalmic solutions. I will be very grateful if anybody can let us know about the fees for filing ANDA. Also briefly explain me about the process and the ways for minimizing the cost.

Usha

Dear Usha

I don’t know the exact fee for filing for ANDA (Abbreviated new drug Application). But I can recommend you to visit FDA 21 CFR 314 (Applications for FDA approval to market a new Drug) for understanding the ANDA process

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314

Thanks and Regards
S. Subramaniam

Information about fees: http://www.fda.gov/oc/pdufa/coversheet.html

Link to other required forms: http://www.fda.gov/cder/Regulatory/applications/ANDA.htm#Forms

Dear Catron,

Thank you for your information. We understood from FDA website that there is no fee for filing ANDA. Also there is no establishment fee for product approved under ANDA.

We very much wondered to hear this information. Is it true? We would like to confirm this information with you. We will be very grateful if you can let us know your or your contact’s practical experience in getting ANDA approval.

If you still have questions, your best bet is to contact FDA directly.

Look at the ANDA forms page (http://www.fda.gov/opacom/morechoices/fdaforms/cder.html) - the last column contains email and phone numbers, or see the Contact CDER (http://www.fda.gov/cder/comment.htm) page.