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 36 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	19b06eaf-0d4c-2b4d-e063-6294a90a2eb9	2024-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	6d1c9a64-c83c-4b3d-9245-704b94cb367c	2024-07-30	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Actavis Pharma, Inc.	3d156d13-25d8-4cfc-8285-5f7ebf48cf45	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	678e2d16-33f3-67a7-e053-2991aa0a1132	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	75d963b9-3675-44ff-bc6b-83461bed1b67	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	57cdd1df-a303-4265-a2d6-1d0b87105a28	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	8df77ead-27eb-4f6f-95a9-f68d3e9cfa71	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	54b25106-5580-119d-e054-00144ff88e88	2024-07-17		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	22cb2ccc-ba4d-4069-8334-f886f0e3e802	2024-07-12	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Foster and Thrive Infants Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	fe3092af-9a7b-4189-af89-31be8d6fed53	2024-07-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	92efad86-31ae-78e5-e053-2995a90a0fda	2024-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3e3848f2-4922-39ea-e054-00144ff88e88	2024-06-25	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	999aa615-72b2-9296-e053-2a95a90ac70b	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	9973bfa2-693a-1165-e053-2995a90a4b1d	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	99d7cf65-3ec2-24eb-e053-2a95a90acc5e	2024-06-20		Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	a2160213-2a32-2044-e053-2995a90a21af	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN 200MG	Lil' Drug Store Products, Inc.	8fc65767-1783-4f7f-8680-9e43ba4d5481	2024-06-19	Warnings	Name fallback brand name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8c3dccbb-1084-cd09-e053-2a95a90ac12a	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8cb93e5f-4ebc-24b7-e053-2a95a90a5a23	2024-06-18	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.