Application 077338

Type: ANDA
Sponsor: P AND L DEV LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	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
A077338-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-07-10

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	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077338-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-07-10	`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 6 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN CAPSULE	PUBLIX SUPER MARKETS INC	10a6eba7-e400-ce97-e063-6294a90af3bd	2026-06-23	Warnings	Name fallback brand name: Ibuprofen
IBUPROFEN	IBUPROFEN	DISCOUNT DRUG MART, INC.	d07ea9e3-88b0-4aa0-903a-10555dcca37d	2026-06-23	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DISCOUNT DRUG MART, INC.	aae40114-343e-12da-e053-2a95a90a9213	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BJWC	0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
pain relief	IBUPROFEN	Bionpharma Inc.	2b4ecdd8-627a-445f-8ddc-f2b6c832c1e8	2026-06-23	Warnings	Name fallback generic name: IBUPROFEN
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	c46c9c36-8844-7b50-e053-2a95a90aa0e9	2026-06-23	Warnings	Name fallback generic name: IBUPROFEN
dye-free pain relief	IBUPROFEN	Bionpharma Inc.	4227d0b7-846a-dcb0-e063-6294a90af7d7	2026-06-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	3c1c1b65-f57f-62b0-e063-6294a90a1021	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	3802982a-2373-9ca3-e063-6394a90a0ab7	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC.	4573753d-117b-a6f2-e063-6394a90ae2f9	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Marketing Association, Inc.	3ed7faff-fd48-0a83-e063-6394a90aab14	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Pain Relief	IBUPROFEN	Albertsons Companies	f9deaeb7-efb3-4019-e053-6394a90a33d6	2026-06-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MEIJER DISTRIBUTION INC.	bc15fea8-0d86-4546-e053-2995a90abee3	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MEIJER DISTRIBUTION INC.	a13ac87b-b395-685e-e053-2a95a90ab5d3	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Whole Foods Market, INC.	32348505-744c-fbfd-e063-6394a90a82d7	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AMERISOURCE BERGEN	1afcf0c6-bd41-4621-9e44-d97b81221c12	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AMERISOURCE BERGEN	a13cee82-1c4e-0cbe-e053-2a95a90a3ab8	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	51de1183-d226-4869-a00a-f6c74e126a39	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	A-S Medication Solutions	25a94943-9acc-49c8-a4da-7e07bb2c35eb	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Topco Associates, LLC	59a88ca7-eb37-46de-9134-a5a6d330bd49	2026-06-23	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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