Application 077328

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;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
A077328-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24
A077328-002	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05
A077328-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24
A077328-004	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30
A077328-005	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30
A077328-006	RISPERIDONE	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2026-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077328-001	AB
A077328-002	AB
A077328-003	AB
A077328-004	AB
A077328-005	AB
A077328-006	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 6 of 6 · 221 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
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077328-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077328-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077328-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-02-24	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077328-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077328-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-11-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 221 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	A077328-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077328-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077328-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077328-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077328-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077328-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077328-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077328-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077328-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077328-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077328-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077328-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077328-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077328-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077328-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077328-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077328-004	AB	1	`b8a1b40f171c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Amerisyn LLC	58b7504f-c4a3-ef1b-e063-6394a90ac0f3	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077328 application number: ANDA077328
Risperidone	RISPERIDONE	Amici Pharma, Inc.	ca41c144-224a-4d57-88d7-8778e6c69ed2	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077328 application number: ANDA077328

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 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-207	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-207	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-208	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-208	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-209	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-209	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-470	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-470	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-471	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-471	Risperidone	Risperidone	Dr. Reddy's Laboratories Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18460	ORIG	2009-03-19