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 32 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	701ee488-c57f-a82c-e053-2991aa0af403	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	19d3af1c-9dd5-48d9-bd5c-05cc8745e836	2025-01-04	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	7cd838e1-85da-4510-86f0-9d8bc913e810	2025-01-03	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	b8f43352-f771-4722-b843-f3e29f77c7c0	2025-01-03	Warnings	Name fallback generic name: IBUPROFEN
Good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	a07c45b4-dc98-4b73-a1c1-84b108cf37e9	2025-01-03	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	9b02607a-6fab-5205-e053-2a95a90afa26	2025-01-02		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fc871659-ce41-1be6-e053-6294a90aa5e4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	998f2fcf-0b40-4304-929f-7f2fa42f66d0	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	09972806-e064-238d-e063-6394a90a7434	2024-12-31	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9af7f4-6314-6217-e053-2995a90a5a0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	b33caad1-8d40-16f2-e053-2a95a90a1b2d	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx Pharmacy of Tennessee, LLC	c859cc7a-e13a-7df4-e053-2a95a90a47d6	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx Pharmacy of Tennessee, LLC	bd1ca7af-d640-23fb-e053-2a95a90a8a98	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Advanced Rx Pharmacy of Tennessee, LLC	f18b6a0a-e42f-083d-e053-2995a90a40e4	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	59c77fd3-5e67-45ec-82ad-44585390c4f3	2024-12-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	2810122e-3c89-49a2-8dac-db3714cb7b45	2024-12-30	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Spirit Pharmaceutical LLC	a96d012e-b132-4e99-b84b-ccd3a9a05cbb	2024-12-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Cabinet Pain Reliever and Fever Reducer	IBUPROFEN	Spirit Pharmaceutical LLC	e172a8d8-779d-4ad9-b6b0-08a198a58034	2024-12-30	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	09bd3935-526d-4ad1-898a-4f0d9499ebb9	2024-12-26	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Chain Drug Marketing Association, Inc.	f0959369-890e-403e-8a98-4eda340a0783	2024-12-23	Warnings	Name fallback 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