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 42 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	759e5cf4-641f-4b3c-bc06-9ee0b4d010fc	2023-03-16	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	f70c1b68-61c8-b333-e053-6294a90aadaa	2023-03-16	Warnings	Name fallback generic name: IBUPROFEN
Advil Liquigels	IBUPROFEN	Navajo Manufacturing Company Inc.	e2c09216-fd63-4d50-9878-62b36236b2e7	2023-03-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3fadcc0-97f5-9f9b-e053-2a95a90aeb54	2023-03-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health (Leader) 70000	e751cb66-5fa5-4171-b061-da34aa10de6c	2023-03-10	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c3f1b721-2bb0-4297-bfc6-7faaf9ba8419	2023-03-09	Warnings	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Proficient Rx LP	ea6f626d-cda3-46e2-9ac9-4e72204cb726	2023-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	1662a495-4f6a-4515-a405-557681e1a496	2023-02-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	a35f04f8-8c7f-5e23-e053-2995a90a30ff	2023-02-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPAK	IBUPROFEN	PureTek Corporation	a63f3857-92d1-0adf-e053-2995a90a3afa	2023-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Topcare Ibuprofen	IBUPROFEN	Topco Associates LLC	742f33fa-8923-4415-bcd6-8db37f2e1974	2023-01-06	Warnings	Name fallback generic name: IBUPROFEN
Flex-Prin	IBUPROFEN	Provision Medical Products	c01538b0-ca4c-434a-be8f-fe023deb84e1	2023-01-05	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	DOLGENCORP INC	8f1358aa-495a-23da-e053-2995a90aa430	2023-01-02	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	WALGREEN COMPANY	4ce20d2b-2dfb-4405-b545-dd1f67b2c588	2022-12-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Migraine Relief	IBUPROFEN	WALGREENS	3d560acb-3334-4a39-9ab1-f131060e3b33	2022-12-28	Warnings	Name fallback generic name: IBUPROFEN
Dye-Free Ibuprofen 200	IBUPROFEN	WALGREEN COMPANY	b9ff2469-22c7-fc70-e053-2a95a90abc49	2022-12-28	Warnings	Name fallback generic name: IBUPROFEN
Dye-Free Ibuprofen 200	IBUPROFEN	WALGREEN COMPANY	bcd15c0f-8231-296f-e053-2995a90a280c	2022-12-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Wal-Mart Stores, Inc.	9e5332ab-92bc-3a33-e053-2995a90a642d	2022-12-28	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Dye-Free Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	d0eff659-6445-a56a-e053-2995a90a72e9	2022-12-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	553d16e1-928e-4919-bc53-6683a035e2b0	2022-12-27	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.