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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203242

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NDA 203242 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Apotex Inc, Hospira, Amphastar Pharm, Gland Pharma Ltd, Sun Pharma Global, Alcon Pharms Ltd, West-ward Pharms Int, Bedford, Claris, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz Inc, Pliva, and Cycle Pharms Ltd, and is included in thirty-eight NDAs. It is available from forty-eight suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for NDA: 203242

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203242

Suppliers and Packaging for NDA: 203242

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 203242 ANDA Fresenius Kabi USA, LLC 76045-104 76045-104-10 24 BLISTER PACK in 1 CARTON (76045-104-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 203242 ANDA Fresenius Kabi USA, LLC 76045-105 76045-105-20 24 BLISTER PACK in 1 CARTON (76045-105-20) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 2 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Oct 7, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Oct 7, 2015TE:APRLD:No


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