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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203410


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NDA 203410 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Alembic, Amphastar Pharm, Apotex Inc, Apothecon, Aspiro, Baxter Hlthcare Corp, Bedford, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Hospira, Luitpold, Nephron, Sagent Pharms Inc, Sandoz, Steriscience, Sun Pharm, Wockhardt, Wockhardt Bio Ag, Chartwell Rx, Epic Pharma Llc, Micro Labs Ltd India, Atnahs Pharma Us, Bionpharma, Hetero Labs Ltd Iii, Leading, Mylan, Pliva, Senores Pharms, Teva, Watson Labs, Zydus, and Lupin Ltd, and is included in fifty-five NDAs. It is available from sixty-four suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 203410
Tradename:KETOROLAC TROMETHAMINE
Applicant:Micro Labs Ltd India
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203410
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 203410
Suppliers and Packaging for NDA: 203410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203410 ANDA Micro Labs Limited 42571-137 42571-137-25 5 mL in 1 BOTTLE (42571-137-25)
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203410 ANDA Micro Labs Limited 42571-137 42571-137-26 10 mL in 1 BOTTLE (42571-137-26)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Apr 5, 2019TE:ATRLD:No

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