Details for New Drug Application (NDA): 210821
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NDA 210821 describes TETRACAINE HYDROCHLORIDE, which is a drug marketed by Alcon Labs and Bausch Lomb Ireland and is included in two NDAs. It is available from six suppliers. Additional details are available on the TETRACAINE HYDROCHLORIDE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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