Application 078828
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.25MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 1MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 2MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 3MG | No | No |
| 006 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078828-001 | RISPERIDONE | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2009-03-23 | |
| A078828-002 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2009-03-23 | |
| A078828-003 | RISPERIDONE | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2009-03-23 | |
| A078828-004 | RISPERIDONE | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2009-03-23 | |
| A078828-005 | RISPERIDONE | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2009-03-23 | |
| A078828-006 | RISPERIDONE | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2009-03-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078828-001 | AB |
| A078828-002 | AB |
| A078828-003 | AB |
| A078828-004 | AB |
| A078828-005 | AB |
| A078828-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2009-03-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2009-03-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2009-03-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2009-03-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2009-03-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078828-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2009-03-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078828-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2009-03-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078828-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2009-03-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078828-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2009-03-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078828-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2009-03-23 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078828-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078828-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078828-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078828-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078828-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078828-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078828-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078828-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078828-006 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A078828-006 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | Golden State Medical Supply, Inc. | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | 078828 ANDA078828 |
| Risperidone | RISPERIDONE | Jubilant Cadista Pharmacuticals Inc. | 39d41b28-93eb-446b-9652-7432858ccbab | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 078828 ANDA078828 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23921 | ORIG | 2009-04-14 |