MedPath
FDA Approval

Analpram HC

December 15, 2017

HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments (2)

Ferndale Laboratories, Inc.

Sebela Pharmaceuticals Inc.

005320536

Albemarle Corporation

Sebela Pharmaceuticals Inc.

788779192

Products (1)

Analpram HC

54766-829

ANDA085979

ANDA (C73584)

TOPICAL

December 15, 2017

STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
LANOLINInactive
Code: 7EV65EAW6HClass: IACT
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OMClass: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5AClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72XClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 3X7931PO74Class: ACTIBQuantity: 25 mg in 1 mL
Code: 88AYB867L5Class: ACTIBQuantity: 10 mg in 1 mL
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