505(b)(2) Approvals list 2019

505(b)(2) approvals of November 2019
Omeprazole, Amoxicillin and Rifabutin DR capsules - Talicia (Redhill biopharma)	Summary
Epinephrine Injection (Hospira)	Summary
Isotretinoin capsules - Absorica LD (Sun Pharma)	Summary
Riluzole oral film (Aquestive)	Summary
Potassium Phosphates Injection (Fresenius Kabi)	Summary

505(b)(2) approvals of October 2019
Dexamethasone tablets (Dexcel Pharma)	Summary
Bortezomib Injections (Dr. Reddy’s)	Summary
Cetirizine Injections (JDP therapeutics)	Summary
Teriparatide Injections (Pfenex)	Summary
Asenapine Transdermal Patch (Hisamitsu)	Summary
Phenylephrine RTU injection (Sintetica SA)	Summary
Minocycline topical foam (Foamix)	Summary
Diroximel fumarate (Alkermes)	Summary

505(b)(2) approvals of September 2019
Fosaprepitant Injections (Teva)	Summary
Glucagon Injections (Xeris)	Summary
Baclofen Oral Solution (Metacel Pharma)	Summary
Potassium phosphates injections (CMP development)	Label

505(b)(2)approvals of August 2019
Fulvestrant (Teva)	Summary
Metformin ER powder for oral suspension – Riomet ER (Sun)	Summary

505(b)(2) approvals of July 2019
Amlodipine Benzoate Suspension - Katerzia (Silvergate)	Summary
Zinc Sulfate Injection (American regents)	Summary
Duloxetine DR Capsules-Drizalma sprinkle (Sun)	Summary
Bivalirudin Solution-Angiomax RTU (Maia pharma)	Summary

Summary on 505(b)(2) approvals of July 2019 available here.

505(b)(2) approvals of Q2 2019
Levothyroxine Sodium IV Solution (Fresenius)	Link
Tranexamic Acid IV Solution; 10 mg/ml (Exela)	Link
Cysteine Hydrochloride IV Solution; 50 mg/ml (Exela)	Link
Selenious Acid IV Solution (American regent)	Link
Fulvestrant (Fresenius)	Link
Midazolam Nasal Spray 5mg/spray (UCB)	Link
Drospirenone 4mg tablets (Exeltis)	Link
Budesonide Extended release (ER) capsules (Sun)	Link
Tiopronin Delayed Release Tablets (Misssion)	Link

Summary on 505(b)2 approvals of July 2019 available here.