Details for New Drug Application (NDA): 208135
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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 208135
Tradename: | TETRACAINE HYDROCHLORIDE |
Applicant: | Alcon Labs |
Ingredient: | tetracaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208135
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 208135
Suppliers and Packaging for NDA: 208135
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | SOLUTION;OPHTHALMIC | 208135 | NDA | Alcon Laboratories, Inc. | 0065-0741 | 0065-0741-14 | 12 BLISTER PACK in 1 CARTON (0065-0741-14) / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER |
TETRACAINE HYDROCHLORIDE | tetracaine hydrochloride | SOLUTION;OPHTHALMIC | 208135 | NDA | REMEDYREPACK INC. | 70518-4183 | 70518-4183-0 | 12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Feb 29, 2016 | TE: | RLD: | Yes |
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