Details for New Drug Application (NDA): 022221
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NDA 022221 describes AKTEN, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the AKTEN profile page.
The generic ingredient in AKTEN is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
The generic ingredient in AKTEN is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-two 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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