MedPath
FDA Approval

Spectracef

June 4, 2013

HUMAN PRESCRIPTION DRUG LABEL

Cefditoren(200 mg in 1 1)

Products (2)

Spectracef

44004-801

NDA021222

NDA (C73594)

ORAL

February 19, 2013

CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
Code: 78THA212DHClass: ACTIMQuantity: 200 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SODIUM CASEINATEInactive
Code: 7473P66J9EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT

Spectracef

44004-802

NDA021222

NDA (C73594)

ORAL

February 19, 2013

Code: 78THA212DHClass: ACTIMQuantity: 400 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM CASEINATEInactive
Code: 7473P66J9EClass: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80JClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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