Application 073691

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073691-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1994-02-25

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073691-001	IBUPROFEN	200MG	TABLET / ORAL	1994-02-25	`f41ea6bd6efb…`

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 7 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	8ea0e303-3967-4d71-8255-ac42a841ce28	2026-06-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	027ded51-aa01-6619-3938-c8162a421cf3	2026-06-18	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Bubblegum Dye Free	IBUPROFEN	CVS	2cf2f35b-5d66-e3ff-e063-6294a90a9b45	2026-06-16	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Granules India Limited	97516b9f-219a-429d-850d-1fe9fd66646b	2026-06-15	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. DBA Leader	a41a0bc2-ef7a-44cd-a42e-aefab41323cc	2026-06-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	01f8fe3a-8810-4b38-8860-d95e05d37709	2026-06-15	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2fa4bfc8-386c-433b-bc46-24fc8ec1bca1	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab80abe6-f7db-479b-e053-2a95a90a90e3	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	ec6b2df4-2f4f-4601-8b53-0542664e0bd9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	57b39311-bc20-ace6-75a9-a07a9311b373	2026-06-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Rite Aid Corporation	d9e698f3-c450-4eaa-9cfd-6f48c2656081	2026-06-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	718a4b73-5f46-4676-afda-f0b4819f5862	2026-06-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	68988a5b-7a6a-4ecd-8006-f2610bac2ad7	2026-06-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	d0301d0d-fc65-420f-87fd-a08da1584d54	2026-06-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Ascend Laboratories, LLC	9ce036ef-a22d-4fca-9a62-1b10978f7b26	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	43c94480-78d1-4a23-91d4-1d49fea72cb7	2026-06-05	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Minis	IBUPROFEN	Vivunt Pharma LLC	c46803db-feb7-435c-ac42-cffa99d35f46	2026-06-04	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Medline industries, LP	5d2482b4-cd90-4246-85a9-fd1d35315b6c	2026-06-04	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Basic Care Ibuprofen	IBUPROFEN	Amazon.com Services LLC	4c1a1543-a2a2-43fb-901c-cf6bcc374a3f	2026-06-03	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	CVS Pharmacy	6d047655-2b29-4f74-ac6e-93b02c25870c	2026-06-01	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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