Application 071735

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
A071735-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-09-10

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	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071735-001	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`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 44 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Pharmaceutical Associates, Inc.	7a6832f2-2d80-483c-bde3-e6cacb7c318a	2022-08-31	Warnings	Name fallback generic name: IBUPROFEN
betr pain relief	IBUPROFEN	Live Betr LLC	1b709dce-5c71-45e6-b516-d510a0a8c25d	2022-08-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e5bf5e09-7d42-6314-e053-2a95a90a2325	2022-08-08	Warnings	Name fallback brand name: Ibuprofen
Ibuprofen	IBUPROFEN	DOLGENCORP, INC.	df321783-73cb-55bf-e053-2a95a90a4ce2	2022-07-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	b7565aac-a928-4116-b9af-cf636da4537c	2022-07-01	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	d2c7f045-e70c-4e2b-b2e0-d81a271d0a04	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	2dc3108f-d917-40c6-865d-c900cf055d1c	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	798d33b0-5d7a-4445-8a51-2a3d336f744a	2022-04-01	Warnings	Name fallback brand name: ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	444b2ea0-ec42-4bcf-b8d2-38b4b297ada0	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	1100648c-6b9f-49c9-94d0-c40f24fe5c27	2022-03-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	9bbbedb3-e0b2-4645-8105-98800096cfed	2022-03-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	0ade8ee2-7c74-4b05-925e-d92742fc2b90	2022-03-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	cf6fbf3b-a0f3-4e08-a981-d183fa285758	2022-03-03	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	91723661-d0bb-4498-ac59-59bbdc334230	2022-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Pain Relief - Ibuprofen 200 mg	IBUPROFEN	Health Pharma USA LLC	d60a6a11-8c06-cede-e053-2a95a90af7f9	2022-01-20	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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