Application 205191

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	SOLUTION/DROPS;OPHTHALMIC	0.4%	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
A205191-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC			2018-11-15

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	A205191-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	2018-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205191-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	2018-11-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205191-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	2018-11-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205191-001	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC	2018-11-15	`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
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Aurobindo Pharma Limited	e93f6501-827d-474c-b660-765b7c0fb871	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205191 application number: ANDA205191 ndc (product): 65862-775

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
65862-775	Ketorolac Tromethamine	Ketorolac Tromethamine	Aurobindo Pharma Limited	ANDA	Current
65862-775	Ketorolac Tromethamine	Ketorolac Tromethamine	Aurobindo Pharma Limited	ANDA	Current
65862-775	Ketorolac Tromethamine	Ketorolac Tromethamine	Aurobindo Pharma Limited	ANDA	Current
65862-775	Ketorolac Tromethamine	Ketorolac Tromethamine	Aurobindo Pharma Limited	ANDA	Current