Application 210755

Type: ANDA
Sponsor: GUARDIAN DRUG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	SUSPENSION/DROPS;ORAL	40MG/ML	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
A210755-001	IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL			2018-09-26

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210755-001	IBUPROFEN	40MG/ML	SUSPENSION/DROPS / ORAL	2018-09-26	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen infants Drops	IBUPROFEN	Harris Teeter, LLC	2c39a24f-4e42-d75f-e063-6394a90a60fa	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Infants Ibuprofen	INFANTS IBUPROFEN	Family Dollar Services, Inc.	13143eb6-2fe8-487b-e063-6294a90a967e	2024-03-27	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Concentrated ibuprofen infants	IBUPROFEN	Chain Drug Marketing Association Inc.	c9ae72d8-d205-4736-9bc4-2325cd77d36b	2023-11-03	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755
Concentrated ibuprofen infants	IBUPROFEN	Guardian Drug Company	3a32f0c7-c03e-4783-a429-08280993ddfb	2022-11-28	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755 ndc (product): 53041-637
Concentrated ibuprofen infants	IBUPROFEN	Wal-Mart Stores, Inc.	00b7fc71-8cf0-4c12-a479-146408f7f91b	2022-01-11	Warnings	Exact identifier application applno (ANDA): 210755 application number: ANDA210755 ndc (product): 49035-635

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49035-635	Concentrated ibuprofen infants	Ibuprofen	Wal-Mart Stores, Inc.	ANDA	Current
49035-635	Concentrated ibuprofen infants	Ibuprofen	Wal-Mart Stores, Inc.	ANDA	Current
53041-637	Concentrated ibuprofen infants	Ibuprofen	Guardian Drug Company	ANDA	Current
53041-637	Concentrated ibuprofen infants	Ibuprofen	Guardian Drug Company	ANDA	Current