Original New Drug Application Approvals by US FDA (01 - 15 July 2022)
18 Jul 2022
New drug applications approved by US FDA as of 01 - 15 July 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
- Active Ingredient(s): Indigotindisulfonate Sodium
- Strength: 40MG/5ML
- Dosage Form(s) / Route(s): Solution; Injection
- Company: Provepharm Sas
- Approval Date: 08 July 2022
- Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
- Indication(s): Indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.
- Approved Label: 08 July 2022 (PDF)