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FDA Approval

Tencon

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 9, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Butalbital(50 mg in 1 1)
Acetaminophen(325 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tencon

Product Details

NDC Product Code
11584-0030
Application Number
ANDA089987
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 9, 2024
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
Code: KHS0AZ4JVKClass: ACTIBQuantity: 50 mg in 1 1
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
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