505(b)(2) Approvals List 2020

505(B)(2) APPROVALS OF 2020

505(b)(2) approvals of January 2020
Diazepam nasal spray (Valtoco)	New Dosage Form	Summary
Octreotide acetate Injection (Bynfezia)	New Formulation	Summary

505(b)(2) approvals of February 2020
Pemetrexed diacid Solution (Pemfexy)	New Formulation	Summary
Cysteamine Bitartarate delayed release granules (Procysbi granules)	New Dosage Form	Summary
Meloxicam Injection (Anjeso)	New Dosage Form	Summary

 

505(b)(2) approvals of March 2020
Romidepsin RTD solution by Teva	New Formulation	Summary

 

505(b)(2) approvals of April 2020
Monomethyl fumarate DR capsules (Bafiertam)	New Active Ingredient	Summary

 

505(b)(2) approvals of May 2020
Celecoxib oral Solution (Elyxyb)	New Dosage form	Summary
Clobetasol propionate topical solution (Impeklo)	New Formulation	Summary
Apomorphine sublingual film (Kynmobi)	New Dosage Form	Summary
Deferiprone delayed release tablets (Ferriprox)	New Formulation	Summary
Minocycline 1.5% topical foam (Zilxi)	New Formulation	Summary