Application 214699

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A214699-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13
A214699-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13
A214699-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214699-001	AB
A214699-002	AB
A214699-003	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 3 · 105 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	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2021-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2021-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214699-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2021-09-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 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	A214699-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214699-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214699-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214699-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214699-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214699-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214699-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214699-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214699-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214699-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214699-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214699-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214699-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214699-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214699-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214699-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214699-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214699-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214699-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214699-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214699-001	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 4 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.	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	e7175dc9-db39-4452-a419-85af179de422	2026-07-16	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	9de61620-6750-4fb6-89a4-fe451ab8d99f	2026-07-15	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuwin Forte	IBUPROFEN	OPMX LLC	0daf1be9-ea38-461e-e063-6394a90a7954	2026-07-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Strides Pharma Science Limited	38ebacc3-378f-483e-babc-76119677e7df	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	f1c88d74-09b0-4b14-baea-106fbbbc54bf	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	3ce7549f-e4db-9f89-e063-6294a90a126d	2026-07-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d6460cc3-c207-44e0-bf78-ad6fef055ed5	2026-07-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	0a98cce4-f5c0-12a8-e063-6294a90a4e7e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	b6a6c940-daf6-4e0e-aefb-35cce87a9a55	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	421156d2-85dc-4680-b2b4-d15b67539e87	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Better Living Brands, LLC	45520969-7a2d-4469-ba25-7db160d50ccf	2026-07-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c0156053-add5-4bd5-b89f-f90df2e73be4	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	20078671-536f-4b0b-a079-f90ac186a670	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ADVIL	IBUPROFEN	Select Consumer Group	3ca752d8-957c-21b4-e063-6294a90a5285	2026-07-03	Warnings	Name fallback generic name: IBUPROFEN
Advil Liquigel	IBUPROFEN	Select Consumer Group	3ca6bc9d-090f-e412-e063-6394a90a6876	2026-07-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	34a9b94f-93ba-4a7c-92eb-d0b4b530d887	2026-07-02	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.