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 47 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	40501966-419a-4ccd-b7c9-5581cbe47a97	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	b6e14f73-1f19-4cfa-8858-136a38ee32d0	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	67e09ad5-e010-4aa1-b86e-9b22331bf33b	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PuraCap Pharmaceutical LLC	24ef6819-f098-4d01-bfe7-6ffa4aa0e671	2019-12-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	50bab3b2-f710-46ff-96cd-1ec4d4658529	2019-11-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	f42506f7-896c-47a9-a4b1-ed72434d7aa0	2019-11-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	58bff8bf-5a4e-4390-9c03-e266d31deb6b	2019-11-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	daf579dc-91d1-4950-b637-c1a34f5542c5	2019-11-22	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sam's West, Inc.	90c301ad-7bbd-4e21-8054-35596b208cd4	2019-11-21	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	72b32512-05c7-4113-b0cc-de9c97de2abb	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bionpharma Inc.	d7d00fe3-c537-486e-8156-9b56b550bff5	2019-09-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Wal-Mart Stores, Inc	c100129d-3754-4d0e-b754-76440d55944a	2019-08-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen 200	IBUPROFEN	WALGREEN COMPANY	5fe0bdfa-1d5b-4657-a32b-f531b69bac0d	2019-08-13	Warnings	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	ffec2f44-1144-4729-b43a-1db40ea6a8d3	2019-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	b234d42e-1333-48a1-8565-35d9759e8085	2019-03-29	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Topco Associates LLC	4aef9935-2e36-4779-a8a8-5288060573af	2019-03-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4a86a190-da5d-4b7a-a05f-e3e7ccbfa603	2019-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Care One ibuprofen childrens	IBUPROFEN	American Sales Company	703869c9-7f12-4556-a2af-8e68942834f2	2018-11-26	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Contract Pharmacal Corp.	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	2018-11-07	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Geritrex LLC	ca9498ec-755d-4a09-9504-210dd48d6fed	2018-10-12	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