Details for New Drug Application (NDA): 210183
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NDA 210183 describes KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Lupin Ltd and is included in one NDA. Additional details are available on the KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE profile page.
The generic ingredient in KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE 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.
The generic ingredient in KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE 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 210183
| Tradename: | KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | ketorolac tromethamine; phenylephrine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | EQ 0.3% BASE;EQ 1% BASE | ||||
| Approval Date: | Jul 1, 2019 | TE: | AT | RLD: | No | ||||
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