Application 076112

Type: ANDA
Sponsor: DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
003	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076112-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31
A076112-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31
A076112-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076112-001	AB
A076112-002	AB
A076112-003	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 4 · 129 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	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2001-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2001-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076112-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2001-10-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076112-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076112-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076112-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076112-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076112-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076112-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076112-001	AB	1	`301d65b070ca…`

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 10 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen Dye Free	IBUPROFEN	CVS Pharmacy	00653b7c-7099-487e-9a01-e89781c21323	2026-04-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Coupler LLC	50766a3d-1a22-be14-e063-6294a90a0ed2	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	36f7227d-f3cb-44b7-a4c1-27611cd15052	2026-04-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Medique at Home Iprin	IBUPROFEN	Sportpharm LLC	954d0436-b681-4bf5-80ec-0de9ddcab994	2026-04-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Costco Wholesale	b4fa56d3-f4be-45b2-a3ac-40fe8d8bea07	2026-04-20	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
care one ibuprofen	IBUPROFEN	American Sales Company	d26d2766-6d4c-462b-ae8b-ef8d87acd633	2026-04-16	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	9291857c-30b3-414b-99e1-9c127e72c0d4	2026-04-16	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen childrens	IBUPROFEN	HyVee Inc	55f8def6-f7de-4b3e-a92a-5cd9e68a46a1	2026-04-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	4e67aef4-c3ac-232a-e063-6394a90a3a85	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	Golden State Medical Supply, Inc.	bbf4821d-f9fc-9f6e-e053-2a95a90a5253	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Good Sense ibuprofen infants	IBUPROFEN	L. Perrigo Company	c79e65e7-149b-450f-b083-99e16ff71729	2026-04-14	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	886c974c-0d32-4a1b-8f54-40c2c12efa45	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
CHILDRENS Ibuprofen	IBUPROFEN	Kesin Pharma Corporation	436c0126-4ff3-c082-e063-6294a90a3d72	2026-04-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	COSTCO WHOLESALE CORPORATION	a50abf26-d6e5-10e4-ea90-a40b96a887e5	2026-04-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	HyVee Inc	3d8497c6-1c46-4248-b75c-b086591529cc	2026-04-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	72e11f2d-a348-4c12-9cd8-1e6f0f6f7399	2026-04-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
care one ibuprofen	IBUPROFEN	American Sales Company	15f63d40-276c-4c02-9f8c-0354e4779916	2026-04-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a348a959-46bc-4ff6-8936-12866fc34a4b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	4a64522f-b7d8-47f7-bf07-c9e8f1086425	2026-04-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Discount Drug Mart	cffad7af-44f5-4e54-9e46-c3c5d4ca182f	2026-04-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49999-042	IBU	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-042	IBU	Ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43052	ORIG	2001-10-31