Details for New Drug Application (NDA): 210821
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The generic ingredient in TETRACAINE HYDROCHLORIDE is tetracaine hydrochloride. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tetracaine hydrochloride profile page.
Summary for 210821
Tradename: | TETRACAINE HYDROCHLORIDE |
Applicant: | Bausch Lomb Ireland |
Ingredient: | tetracaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210821
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 210821
Suppliers and Packaging for NDA: 210821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | SOLUTION;OPHTHALMIC | 210821 | NDA | Bausch Health US LLC | 0187-0920 | 0187-0920-05 | 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE |
TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | SOLUTION;OPHTHALMIC | 210821 | NDA | Bausch & Lomb Incorporated | 24208-092 | 24208-092-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-092-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Mar 12, 2019 | TE: | RLD: | Yes |
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