Application 071265

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
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071265-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1986-10-15
A071265-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`782e0a99824c…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Contract Pharmacal Corp.	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	2018-11-07	Warnings	Exact identifier application applno (ANDA): 071265 application number: ANDA071265 ndc (product): 10267-3909 ndc (product): 10267-3852 ndc (product): 10267-3846

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10267-3846	ibuprofen	ibuprofen	Contract Pharmacal Corp.	ANDA	Current
10267-3852	ibuprofen	ibuprofen	Contract Pharmacal Corp.	ANDA	Current
10267-3909	ibuprofen	ibuprofen	Contract Pharmacal Corp.	ANDA	Current