Basic Information
Propafenone Hydrochloride
24979-087
Regulatory Information
24979-087
ANDA212928
C73584
June 20, 2020
USA
These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral useInitial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
6
Company Information
658402052
Active Ingredients
Potassium Hydroxide
Code: WZH3C48M4T
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
HYPROMELLOSE 2910 (3 MPA.S)
Code: 0VUT3PMY82
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
Magnesium Stearate
Code: 70097M6I30
Class Code: IACT
Sodium Lauryl Sulfate
Code: 368GB5141J
Class Code: IACT
Titanium Dioxide
Code: 15FIX9V2JP
Class Code: IACT
Shellac
Code: 46N107B71O
Class Code: IACT
Propylene Glycol
Code: 6DC9Q167V3
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U