Details for New Drug Application (NDA): 022221
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The generic ingredient in AKTEN is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 022221
Tradename: | AKTEN |
Applicant: | Thea Pharma |
Ingredient: | lidocaine hydrochloride |
Patents: | 1 |
Pharmacology for NDA: 022221
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 022221
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AKTEN | lidocaine hydrochloride | GEL;OPHTHALMIC | 022221 | NDA | Thea Pharma Inc. | 82584-792 | 82584-792-01 | 1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE |
AKTEN | lidocaine hydrochloride | GEL;OPHTHALMIC | 022221 | NDA | Thea Pharma Inc. | 82584-792 | 82584-792-25 | 25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;OPHTHALMIC | Strength | 3.5% | ||||
Approval Date: | Oct 7, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 24, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE |
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