Claravis
CLARAVIS™(isotretinoin capsules USP)
Approved
Approval ID
ee862463-77c0-4694-bba8-97274f13963f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2014
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6185
Application NumberANDA076135
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2014
FDA Product Classification
INGREDIENTS (20)
ISOTRETINOINActive
Quantity: 30 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6308
Application NumberANDA076135
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2014
FDA Product Classification
INGREDIENTS (19)
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6307
Application NumberANDA076135
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2014
FDA Product Classification
INGREDIENTS (17)
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT