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FDA Drug information

Isotretinoin

Read time: 1 mins
Marketing start date: 30 Apr 2024
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Summary of product characteristics


Effective Time

20230901

Version

1

Spl Product Data Elements

Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN ALCOHOL AMMONIA BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN GLYCERIN HYDROGENATED SOYBEAN OIL ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL SOYBEAN OIL TITANIUM DIOXIDE WATER WHITE WAX reddish brown 1022 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN ALCOHOL AMMONIA BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN GLYCERIN HYDROGENATED SOYBEAN OIL ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL SOYBEAN OIL TITANIUM DIOXIDE WATER WHITE WAX CREAM 1023 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN BUTYLATED HYDROXYANISOLE FERRIC OXIDE RED FERRIC OXIDE YELLOW GELATIN GLYCERIN HYDROGENATED SOYBEAN OIL FERROSOFERRIC OXIDE SOYBEAN OIL TITANIUM DIOXIDE WHITE WAX AMMONIA ALCOHOL ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL WATER EDETATE DISODIUM BEIGE 1024 Isotretinoin Isotretinoin ISOTRETINOIN ISOTRETINOIN ALCOHOL AMMONIA BUTYLATED HYDROXYANISOLE EDETATE DISODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN GLYCERIN HYDROGENATED SOYBEAN OIL ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL 400 POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL SOYBEAN OIL TITANIUM DIOXIDE WATER WHITE WAX LIGHT BROWN 1025

Application Number

ANDA211568

Brand Name

Isotretinoin

Generic Name

Isotretinoin

Product Ndc

70771-1558

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1557-8 Isotretinoin Capsules, USP 10 mg 30 Capsules Rx only NDC 70771-1558-8 Isotretinoin Capsules, USP 20 mg 30 Capsules Rx only NDC 70771-1559-8 Isotretinoin Capsules, USP 30 mg 30 Capsules Rx only NDC 70771-1560-8 Isotretinoin Capsules, USP 40 mg 30 Capsules Rx only 10 mg front label 10 mg back 20 mg front 20 mg back 30 mg front 30 mg back 40 mg front 40 mg back

Spl Unclassified Section

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Drug section

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