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 39 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN 200 MG	IBUPROFEN	Basic Drugs, Inc.	d3351d44-2078-3adc-e053-2995a90a3c8f	2024-01-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	59f14d2b-f48a-4c25-bea3-3dc9100898b2	2023-12-31	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	ee241be0-35f8-4789-a71f-98de31d6a590	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0	2023-12-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals NY LLC	e07d989d-1b0e-4cc1-abf2-93c8b208a29a	2023-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	DEMOULAS SUPERMARKETS INC.	4ca54293-9e81-4b24-8112-734f28cd2c55	2023-12-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bionpharma Inc.	4bc6e8f2-ba95-4352-80ed-b44608fc4936	2023-12-27	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Dye-Free Ibuprofen	IBUPROFEN	RITE AID CORPORATION	c1c58a2d-9ffd-69d0-e053-2a95a90a5718	2023-12-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f1f1e0ac-6944-4123-9e08-1df91582d457	2023-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8553e29a-7f6f-4ff8-9991-836e619c504d	2023-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	American Health Packaging	bc69d88b-d9af-4010-8e8f-e761a9e295a9	2023-12-05	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	7152b6ce-6113-4003-bf80-aa263be69392	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	400faee1-f662-470e-bcd6-7711dfaf9ba2	2023-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	e210c707-2bae-44a5-93dc-459dd24fd960	2023-11-20	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	c7e59784-a338-4922-a806-98c7505957cd	2023-11-10	Warnings	Name fallback generic name: IBUPROFEN
Concentrated ibuprofen infants	IBUPROFEN	Chain Drug Marketing Association Inc.	c9ae72d8-d205-4736-9bc4-2325cd77d36b	2023-11-03	Warnings	Name fallback generic name: IBUPROFEN
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	68d67a25-e669-47c7-8410-9f304b914ff1	2023-10-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Geri-Care Pharmaceutical Corp	0744c3ca-4224-4f6a-a033-880949b544fd	2023-10-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	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