Application 071773

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPRIN	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
A071773-001	IBUPRIN	IBUPROFEN	200MG	TABLET / ORAL			1987-07-16

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	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071773-001	IBUPRIN	200MG	TABLET / ORAL	1987-07-16	`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 3 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	b5a47efe-222f-4cbd-b649-caafd16a0829	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	9d5c994a-8363-4ddb-956c-e12b79a32a58	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	87ffbf01-54de-45a8-b2a3-367d21927882	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Harris Teeter	1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
ADVIL MIGRAINE	IBUPROFEN	Haleon US Holdings LLC	e4a6219d-4ad4-0119-4cf8-7fc39b4b5979	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Advil	IBUPROFEN	Haleon US Holdings LLC	1f01c10a-9434-91a4-2ee4-352315a6b610	2026-07-29	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a7756b22-73cf-4262-aa8e-0577ddecd03b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	1ca722bb-940e-4b3e-9561-d87e2feb1ff8	2026-07-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fc6c29b4-f1b3-4cfe-8c96-564d083be39c	2026-07-24	Warnings	Name fallback generic name: IBUPROFEN
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	HF Acquisition Co LLC, DBA HealthFirst	574b6f15-70bc-fca7-e063-6294a90a0455	2026-07-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Safeway, Inc.	a530d43d-e9c4-4edb-af66-c92860e46f45	2026-07-23	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TWIN MED LLC	f03958f8-aeae-edf0-e053-2a95a90a3e9e	2026-07-22	Warnings	Name fallback generic name: IBUPROFEN
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2026-07-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	d3a7ebef-f7ab-4b34-b62e-278a8deabf78	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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