Invirase (saquinavir mesylate) Capsules

NDA 20628/S-034

Hoffmann-La Roche, Inc.

HIV-1 infection

0 to < 4 months

11/30/2012

Invirase (saquinavir mesylate) Tablets

NDA 021785/S-011

Hoffmann-LaRoche, Inc.

HIV-1 infection

0 to < 4 months

11/30/2012

Qnasl (beclomethasone dipropionate) Nasal Aerosol Spray

NDA 202813

Teva

Perennial allergic rhinitis

0 to < 4 years

12/5/2012

Hysingla ER (hydrocodone bitartrate) Extended-Release Tablets

NDA 206627

Purdue Pharma L.P.

Pain severe enough to require daily, around-the-clock, long-term opioid treatment

7 to < 12 years       

11/20/2014

Qudexy XR (topiramate extended-release) Capsules

NDA 205122

Upsher-Smith Laboratories, Inc.

Adjunctive therapy in partial onset seizures (POS)

1 to 6 months

3/30/2018

Aemcolo (rifamycin) Delayed-Release Tablets

NDA 210910

Cosmo Technologies, Ltd.

Travelers’ diarrhea caused by noninvasive strains of Escherichia coli

3 to 5 years

11/16/2018

Total

6