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 23 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline childrens ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	3a166a74-cdc4-4620-b796-750464e15dc0	2025-08-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BJWC (Berkley & Jensen / BJ's)	2f322afb-bfc8-9dab-e063-6394a90a08b5	2025-08-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	9372c47d-2a3c-4f44-86f8-7568657844e7	2025-08-19	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	63b8d389-7feb-41d2-8970-b7d5660ccb4a	2025-08-14	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	FSA STORE INC.	ec6b1b86-46fc-7e82-e053-2a95a90ac147	2025-08-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	fbbc67a7-359f-4155-9367-3815c05ccf03	2025-08-08	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	59b881f9-1830-4bce-99d2-9770c9b2575f	2025-08-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PROSTAT FIRST AID	3bca27b4-3df6-b7d1-e063-6394a90ac6af	2025-08-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9ac948-440c-5abf-e053-2995a90af2b5	2025-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	EQUATE (WAL-MART STORES, INC.)	104b5ac1-9c5e-40f8-a9b1-1761b495bb1c	2025-08-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	3b9fdc48-c071-4e2c-e063-6294a90a679f	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Meijer, Inc.	eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b	2025-08-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	d7ed42c4-371c-4a54-ab15-0630656f0427	2025-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	3b17587e-b609-42a9-e063-6294a90ab1f8	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	PAI Holdings, LLC dba PAI Pharma	c26cefe0-182a-4b03-baeb-b3eb2e0e2267	2025-08-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0e95aab9-3a7c-49c3-b8df-f66d6f31aee0	2025-07-31	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	47657d95-4a54-49c2-8273-86b413b8f41e	2025-07-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Publix Super Markets Inc	54ae0273-4d8d-4c3b-85ff-675ba96f00de	2025-07-22	Warnings	Name fallback generic name: IBUPROFEN
INFANTS IBUPROFEN	IBUPROFEN	Safeway	6fed7c65-69a3-4899-a85d-23ea95f571a4	2025-07-21	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	SOLA Pharmaceuticals, LLC	44fb0842-c34e-477e-96df-350cd5d6800e	2025-07-20	Boxed warning, Warnings, Adverse reactions	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