MedPath
FDA Approval

Myorisan

January 2, 2013

HUMAN PRESCRIPTION DRUG LABEL

Isotretinoin(40 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (2)

Myorisan

54868-6366

ANDA076485

ANDA (C73584)

ORAL

January 2, 2013

Code: EH28UP18IFClass: ACTIBQuantity: 40 mg in 1 1
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Myorisan

54868-6378

ANDA076485

ANDA (C73584)

ORAL

January 2, 2013

SORBITOLInactive
Code: 506T60A25RClass: IACT
Code: EH28UP18IFClass: ACTIBQuantity: 20 mg in 1 1
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SOYBEAN OILInactive
Code: 241ATL177AClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
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