NDC 82584-792

AKTEN

Lidocaine Hydrochloride Anhydrous

AKTEN is a Ophthalmic Gel in the Human Prescription Drug category. It is labeled and distributed by Thea Pharma Inc.. The primary component is Lidocaine Hydrochloride Anhydrous.

Product ID82584-792_ed743bff-b30e-5b46-e053-2995a90acc42
NDC82584-792
Product TypeHuman Prescription Drug
Proprietary NameAKTEN
Generic NameLidocaine Hydrochloride Anhydrous
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-12-01
Marketing CategoryNDA /
Application NumberNDA022221
Labeler NameThea Pharma Inc.
Substance NameLIDOCAINE HYDROCHLORIDE ANHYDROUS
Active Ingredient Strength35 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 82584-792-01

1 TUBE in 1 CARTON (82584-792-01) > 1 mL in 1 TUBE
Marketing Start Date2022-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "AKTEN" or generic name "Lidocaine Hydrochloride Anhydrous"

NDCBrand NameGeneric Name
17478-792AktenLidocaine Hydrochloride
82584-792AKTENLIDOCAINE HYDROCHLORIDE ANHYDROUS
0404-9887Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
0404-9888Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
0404-9895Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
52584-276Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride Anhydrous
55154-0124Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
55154-2371Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
55154-2373Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
55154-3187Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
55154-6984Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
55154-6992Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
61699-4276Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
61699-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
63739-469Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUS
65282-1605Lidocaine Hydrochloridelidocaine hydrochloride anhydrous

Trademark Results [AKTEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AKTEN
AKTEN
77012922 3631872 Live/Registered
Akorn Inc.
2006-10-03
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