Home Applications 210183 Application 210183
Type ANDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE SOLUTION;IRRIGATION EQ 0.3% BASE;EQ 1% BASE 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 A210183-001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT 2019-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210183-001 AT
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 Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A210183-001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT 2019-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210183-001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT 2019-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210183-001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT 2019-07-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210183-001 KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT 2019-07-01 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 59608 ORIG 2019-08-07