Details for New Drug Application (NDA): 215816
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NDA 215816 describes PROPARACAINE HYDROCHLORIDE, which is a drug marketed by Bausch And Lomb, Mankind Pharma, Micro Labs, Rising, Sola Barnes Hind, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the PROPARACAINE HYDROCHLORIDE profile page.
The generic ingredient in PROPARACAINE HYDROCHLORIDE is proparacaine hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
The generic ingredient in PROPARACAINE HYDROCHLORIDE is proparacaine hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 215816
| Tradename: | PROPARACAINE HYDROCHLORIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | proparacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215816
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 215816
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPARACAINE HYDROCHLORIDE | proparacaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 215816 | ANDA | Somerset Therapeutics, LLC | 70069-601 | 70069-601-01 | 1 BOTTLE in 1 CARTON (70069-601-01) / 15 mL in 1 BOTTLE |
| PROPARACAINE HYDROCHLORIDE | proparacaine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 215816 | ANDA | Sportpharm, Inc. dba Sportpharm | 85766-039 | 85766-039-15 | 1 BOTTLE in 1 CARTON (85766-039-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Aug 9, 2024 | TE: | AT | RLD: | No | ||||
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