Application 213565

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET;ORAL	200MG;30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL			2023-03-10

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213565-001	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL	2023-03-10	`a50c72e98297…`

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 and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	c01116d3-32f8-41f0-8e31-c4142265ef56	2024-10-24	Warnings	Exact identifier application applno (ANDA): 213565 application number: ANDA213565

Reported adverse events (FAERS/openFDA)#

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