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AQUASOL A

NDA

VITAMIN A PALMITATE | N006823 | CASPER PHARMA LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Immune-Mitochondrial Correction in Military Recruits NCT07622147	N/A	Not Yet Recruiting	MIPO Clinic	200	2027-01-01 → 2028-12
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma NCT06172296	Phase 3	Recruiting	National Cancer Institute (NCI)	478	2024-04-19 → 2029-12-31
Probiotics for Women NCT07364383	N/A	Completed	Cultech Ltd	40	2026-01-22 → 2026-04-20
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma NCT01041638	Phase 3	Completed	National Cancer Institute (NCI)	105	2009-12-21 → 2021-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

DSM-FIRMENICH SWITZERLAND AGVITAMIN A PALMITATE 1.7 MIU/G (WITHOUT STABILIZERS)

DMF 310382016

BASF SEInactiveVITAMIN A PALMITATE

DMF 65811986

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 50,000 UNITS BASE/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.