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 12 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	ae50a548-dc32-4c5b-b133-c6537267127b	2026-03-11	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	0550fa2f-f25e-4abb-b10e-a3d05bdb3217	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	c38a03fa-6b9a-4737-a848-063ca5c580b9	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUOROFEN	Direct_Rx	90b8b80e-ab30-3590-e053-2a95a90a70ef	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IBUPROFEN
Ibuprofen	IBUPROFEN	Legacy Pharmaceutical Packaging, LLC	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Direct_Rx	1aa11b52-1aca-9219-e063-6294a90a470f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Minis	IBUPROFEN	Grocery Outlet, Inc.	44665e3d-37a7-a1a7-e063-6294a90ab376	2026-03-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	ab2f1a30-611b-41b6-9baf-6a82305da845	2026-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CVS Pharmacy	ef204cc0-4009-4dd0-83e2-2b5ad6f98409	2026-02-27	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	CVS Pharmacy	215e2275-2968-419c-9a89-8dbb3b4f4d2e	2026-02-27	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	CVS Pharmacy	e28d0916-8165-431c-a19c-ef7d4bb6b8e6	2026-02-26	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	d673266c-3d2b-479f-9b53-cdd1b8651393	2026-02-25	Warnings	Name fallback generic name: IBUPROFEN
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	7817923f-4c21-4943-a7e2-dad4e2915fc4	2026-02-23	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	HyVee Inc	c20a9bc5-e481-4fb2-ad10-d01e83e43ca0	2026-02-21	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522b794-5c93-44cd-e063-6394a90ab39a	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	4b34b58b-2cf7-9aa8-e063-6294a90a0658	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
CVS Ibuprofen	IBUPROFEN	CVS Pharmacy	3d71e29f-0648-7377-e063-6294a90a8a29	2026-02-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0170876a-d8cd-4a2d-8397-db2acdf72ffb	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Childrens	IBUPROFEN	Major Pharmaceuticals	9d56e64d-7860-4fd1-88d2-c537e50079d8	2026-02-13	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	HyVee Inc	d522a3ac-dd43-4faa-b3f8-69313be1c829	2026-02-11	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.