Application 213788
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BREXPIPRAZOLE | BREXPIPRAZOLE | TABLET; ORAL | 0.25MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | 6991c065-0f6e-433a-8f4f-796e0ece327f | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Rexulti | BREXPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | 2d301358-6291-4ec1-bd87-37b4ad9bd850 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Rexulti | BREXPIPRAZOLE | REMEDYREPACK INC. | df891816-3fdb-4347-8bf0-c18bc40f1d70 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | BREXPIPRAZOLE |
| Brexpiprazole | BREXPIPRAZOLE | Ajanta Pharma USA Inc. | 993b584c-7fe6-4551-899f-39146c8508ac | 2022-12-13 | Boxed warning, Warnings, Adverse reactions | Brexpiprazole BREXPIPRAZOLE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68531 | ORIG | 2021-09-02 |