Home Applications 021346 Application 021346
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RISPERDAL CONSTA RISPERIDONE INJECTABLE;INTRAMUSCULAR 25MG/VIAL Yes Yes 002 RISPERDAL CONSTA RISPERIDONE INJECTABLE;INTRAMUSCULAR 37.5MG/VIAL Yes No 003 RISPERDAL CONSTA RISPERIDONE INJECTABLE;INTRAMUSCULAR 50MG/VIAL Yes No 004 RISPERDAL CONSTA RISPERIDONE INJECTABLE;INTRAMUSCULAR 12.5MG/VIAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021346-001 RISPERDAL CONSTA RISPERIDONE 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-002 RISPERDAL CONSTA RISPERIDONE 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-003 RISPERDAL CONSTA RISPERIDONE 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 N021346-004 RISPERDAL CONSTA RISPERIDONE 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table 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 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021346-001 RISPERDAL CONSTA 25MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-003 RISPERDAL CONSTA 50MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2003-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL POWDER / INTRAMUSCULAR AB RLD, RS 2007-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-001 RISPERDAL CONSTA 25MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD, RS 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-002 RISPERDAL CONSTA 37.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-003 RISPERDAL CONSTA 50MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2003-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021346-004 RISPERDAL CONSTA 12.5MG/VIAL INJECTABLE / INTRAMUSCULAR AB RLD 2007-04-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021346-001 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6667061 2020-05-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-003 6667061*PED 2020-11-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6194006*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6379703*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021346-004 6596316*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021346-001 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-002 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-003 6667061 2020-05-25 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021346-003 6667061*PED 2020-11-25 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021346-001 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-001 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-002 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-002 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-003 6667061 2020-05-25 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021346-003 6667061*PED 2020-11-25 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021346-001 6194006*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6379703*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6596316*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6667061 2020-05-25 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-001 6667061*PED 2020-11-25 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6194006*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6379703*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6596316*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6667061 2020-05-25 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021346-002 6667061*PED 2020-11-25 Pediatric extension 3f01610625f2…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50458-306 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-306 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-306 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-306 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-306 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-307 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-307 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-307 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-307 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-307 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-308 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-308 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-308 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-308 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-308 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-309 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-309 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-309 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-309 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current 50458-309 RISPERDAL CONSTA risperidone Janssen Pharmaceuticals, Inc. NDA Current