Application 201003

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201003-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24
A201003-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24
A201003-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24
A201003-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24
A201003-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24
A201003-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A201003-001	AB
A201003-002	AB
A201003-003	AB
A201003-004	AB
A201003-005	AB
A201003-006	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.

Product history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-08-24	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201003-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201003-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201003-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201003-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201003-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201003-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201003-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201003-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201003-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201003-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201003-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201003-004	AB	1	`fd3edfee7708…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Proficient Rx LP	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	088dc3dd-7740-471b-8c06-5a47900ae5b5	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003
RISPERIDONE	RISPERIDONE	Proficient Rx LP	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003 ndc (product): 71205-520
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ac152803-d75f-4c3c-bc49-8663b21a3a82	2019-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201003 application number: ANDA201003 ndc (product): 71610-264

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 135 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1502	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1568	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1575	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1613	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1631	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1631	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
70518-1771	RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ANDA	Current
71205-520	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
71205-520	RISPERIDONE	RISPERIDONE	Proficient Rx LP	ANDA	Current
71335-0130	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0130	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0130	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0459	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0626	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0626	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0626	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0740	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0740	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0740	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0885	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71335-0885	RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	ANDA	Current
71610-145	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-145	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-226	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-246	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-246	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-264	RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current