NDC 68968-0173

SECUADO

Asenapine

SECUADO is a Transdermal Film, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Noven Therapeutics, Llc. The primary component is Asenapine.

Product ID68968-0173_584854cb-d9a5-44e0-adaa-50ebbad1c6e7
NDC68968-0173
Product TypeHuman Prescription Drug
Proprietary NameSECUADO
Generic NameAsenapine
Dosage FormFilm, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2020-02-12
Marketing CategoryNDA / NDA
Application NumberNDA212268
Labeler NameNoven Therapeutics, LLC
Substance NameASENAPINE
Active Ingredient Strength6 mg/d
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68968-0173-3

30 POUCH in 1 CARTON (68968-0173-3) > 1 d in 1 POUCH
Marketing Start Date2020-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68968-0173-3 [68968017303]

SECUADO FILM, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212268
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-12

Drug Details

Active Ingredients

IngredientStrength
ASENAPINE5.7 mg/d

Pharmacological Class

  • Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "SECUADO" or generic name "Asenapine"

NDCBrand NameGeneric Name
68968-0172SECUADOASENAPINE
68968-0173SECUADOASENAPINE
68968-0174SECUADOASENAPINE
42794-016ASENAPINEASENAPINE
42794-017ASENAPINEASENAPINE
46708-198AsenapineAsenapine
46708-199AsenapineAsenapine
46708-544AsenapineAsenapine
62332-198AsenapineAsenapine
62332-199AsenapineAsenapine
62332-544AsenapineAsenapine

Trademark Results [SECUADO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SECUADO
SECUADO
87659437 5646398 Live/Registered
HISAMITSU PHARMACEUTICAL CO., INC.
2017-10-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.