Basic Information
Propafenone Hydrochloride
0591-2286
Regulatory Information
0591-2286
ANDA202688
C73584
May 1, 2019
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 use Initial U.S. Approval: 1989
HUMAN PRESCRIPTION DRUG LABEL
24
Company Information
119723554
Active Ingredients
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
Active Moieties
PROPAFENONE
Code: 68IQX3T69U