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 37 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	88795f0e-41b7-504e-e053-2995a90a3b9e	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen, Circle K, 50ct	IBUPROFEN	Lil' Drug Store Products, Inc.	1ab6fbae-ead5-283b-e063-6394a90a4ed4	2024-06-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	114b5e23-6cd7-41d8-e063-6294a90aa0f0	2024-06-12	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6d86ce94-a06a-2769-e053-2991aa0afb95	2024-06-10		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	6365b2d6-2337-70c0-e053-2a91aa0aa960	2024-06-06		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	SKYA HEALTH, LLC	1c28af16-7246-4e4c-a1be-939655c37242	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen, Lil Drug Store	IBUPROFEN	Lil' Drug Store products, Inc.	18e80dab-6837-fd2d-e063-6294a90a73c8	2024-05-20	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN 100	IBUPROFEN	JHK Inc dba American Safety & First Aid	218f6df9-dd04-45b6-8a45-3276691abee2	2024-04-25	Warnings	Name fallback generic name: IBUPROFEN
JUNIOR STRENGTH ADVIL	IBUPROFEN	Haleon US Holdings LLC	5ed0d404-c54d-b05f-578a-d2730e8a78ee	2024-04-22	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Kroger Company	bc178013-ab2e-04f5-e053-2995a90a1ed4	2024-04-13	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	KROGER COMPANY	0fbe42d0-b5f2-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Name fallback brand name: Ibuprofen
Ibuprofen	IBUPROFEN	KROGER COMPANY	0fbe42d0-b5f0-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	b514b589-d965-4a21-91b3-fab4019e9d96	2024-04-12	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	H E B	e00acbc0-352e-4ba1-8433-18a3079f6743	2024-04-12	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Infants Ibuprofen	IBUPROFEN	Aurohealth LLC	2a48af51-23e2-4fec-a76b-eef1611750f5	2024-04-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Sam's West, Inc	74ad11b9-8976-463d-89a3-2b9f5acd0c80	2024-04-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Advil Liqui-Gels	IBUPROFEN	Lil Drug Store Products, Inc	ba5a9a04-993e-4fd6-bb40-6edfdfb69b34	2024-03-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	141b7964-cce6-74e4-e063-6294a90af746	2024-03-20	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.