Tentative Approval Letter FDA Letters

FDA issued a tentative approval letter for ANDA 220197 on 2026-07-22. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SCOMARA on 2026-07-22. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for RUXOLITINIB on 2026-07-22. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for UBROGEPANT on 2026-07-22. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for UBROGEPANT on 2026-07-21. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for LAROTRECTINIB on 2026-07-21. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for TIVOZANIB on 2026-07-21. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220143 on 2026-07-21. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CEFTRIAXONE on 2026-07-21. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220724 on 2026-07-21. The source metadata identifies ANDA 220724 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219413 on 2026-07-21. The source metadata identifies ANDA 219413 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for PEMIGATINIB on 2026-07-21. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220866 on 2026-07-21. The source metadata identifies ANDA 220866 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219346 on 2026-07-21. The source metadata identifies ANDA 219346 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for EDARAVONE on 2026-07-21. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ABANTA on 2026-07-02. The source metadata identifies NDA 221024 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 218760 on 2026-06-09. The source metadata identifies ANDA 218760 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211563 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 212211 on 2026-06-09. The source metadata identifies ANDA 212211 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220169 on 2026-06-08. The source metadata identifies ANDA 220169 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220025 on 2026-06-08. The source metadata identifies ANDA 220025 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220352 on 2026-06-08. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CENOBAMATE on 2026-06-05. The source metadata identifies ANDA 219473 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CYCLOPHOSPHAMIDE on 2026-06-05. The source metadata identifies ANDA 219271 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 217060 on 2026-06-02. The source metadata identifies ANDA 217060 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for MILNACIPRAN HYDROCHLORIDE on 2026-06-02. The source metadata identifies ANDA 210944 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 217786 on 2026-06-02. The source metadata identifies ANDA 217786 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 212283 on 2026-06-02. The source metadata identifies ANDA 212283 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SITAGLIPTIN PHOSPHATE on 2026-06-02. The source metadata identifies ANDA 215155 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219257 on 2026-05-26. The source metadata identifies ANDA 219257 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on 2026-05-05. The source metadata identifies NDA 219804 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for KITPROZY on 2026-03-23. The source metadata identifies NDA 220712 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220327 on 2026-03-20. The source metadata identifies ANDA 220327 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for MACITENTAN on 2026-03-19. The source metadata identifies ANDA 211000 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for AFATINIB on 2026-03-19. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219440 on 2026-02-11. The source metadata identifies ANDA 219440 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for RIFAXIMIN on 2026-02-11. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SELENIOUS ACID on 2026-02-11. The source metadata identifies ANDA 220051 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220525 on 2026-02-11. The source metadata identifies ANDA 220525 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for AMPHETAMINE on 2026-02-11. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling.