Application 076440

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	SOLUTION;ORAL	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076440-001	RISPERIDONE	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA		2009-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076440-001	AA

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL	AA	2009-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076440-001	RISPERIDONE	1MG/ML	SOLUTION / ORAL		2009-01-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076440-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076440-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076440-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076440-001	AA	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A076440-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076440-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076440-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076440-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076440-001	AA	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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	ANI Pharmaceuticals, Inc.	1f47ec91-602f-4fba-8f7e-a5698760b655	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076440 application number: ANDA076440

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23823	ORIG	2009-02-04