Application 203775
- Type
- ANDA
- Sponsor
- RISING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEVIMELINE HYDROCHLORIDE | CEVIMELINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203775-001 | CEVIMELINE HYDROCHLORIDE | CEVIMELINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AB | 2014-06-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203775-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A203775-001 | CEVIMELINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AB | 2014-06-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A203775-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cevimeline Hydrochloride | CEVIMELINE HYDROCHLORIDE | ASCLEMED USA INC. | bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc4 | 2026-05-18 | Warnings, Adverse reactions | 203775 ANDA203775 |
| Cevimeline Hydrochloride | CEVIMELINE HYDROCHLORIDE | Bryant Ranch Prepack | 51307f82-66f2-41c7-80ff-174d7e50f7ee | 2024-09-05 | Warnings, Adverse reactions | 203775 ANDA203775 |
| Cevimeline Hydrochloride | CEVIMELINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | d4bd942a-1339-40c5-8fd4-850da5a69635 | 2024-08-02 | Warnings, Adverse reactions | 203775 ANDA203775 16571-657 |