Amnesteem
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Approved
Approval ID
b2cb63c9-f825-4991-9a2c-6260f1bbcc2c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-6611
Application NumberANDA075945
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2021
FDA Product Classification
INGREDIENTS (9)
ISOTRETINOINActive
Quantity: 10 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6612
Application NumberANDA075945
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2021
FDA Product Classification
INGREDIENTS (11)
ISOTRETINOINActive
Quantity: 20 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
isotretinoin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6614
Application NumberANDA075945
Product Classification
M
Marketing Category
C73584
G
Generic Name
isotretinoin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2021
FDA Product Classification
INGREDIENTS (11)
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
ISOTRETINOINActive
Quantity: 40 mg in 1 1
Code: EH28UP18IF
Classification: ACTIB