Mylan Pharmaceuticals Inc.: NDA 204311

Submit draft labeling based on our proposed revisions sent to you separately via email correspondence on August 6, 2019.

(4) Submit draft labeling based on our proposed revisions sent to you separately via email on August 6, 2019.

'ake before the application may be approved.

Please refer to your New Drug Application (NDA) dated May 2, 2014, received May 5, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for acetaminophen ® for injection, 1 g/vial.

Please refer to your New Drug Application (NDA) dated and received December 23, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for the following drug product:

We completed our review of this application.

This determination is based upon information available to the Agency at this time [i.e., information in your application and the status of current good manufacturing practices (CGMPs) of the facilities used in manufacturing and testing of the drug product].

If you have questions as to when this date will be, please contact the Agency at the information provided below.

Two or six months prior to the expiration of the patent and exclusivity protection, as appropriate, submit an amendment to this application identifying changes, if any, in the conditions under which your product was tentatively approved.

Your amendment should include updated labeling, chemistry, manufacturing and controls data, and a safety update.

Until we issue a final approval letter, this NDA is not deemed approved.

If you believe that there are grounds for issuing the final approval letter before the period of patents' protection has expired, you should amend your application accordingly.