NDC 72143-231

ACCUTANE

Isotretinoin

ACCUTANE is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Jg Pharma Inc.. The primary component is Isotretinoin.

Product ID72143-231_a599c5e2-aeaa-4667-b6fa-ddc56bbb71da
NDC72143-231
Product TypeHuman Prescription Drug
Proprietary NameACCUTANE
Generic NameIsotretinoin
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2021-01-11
Marketing CategoryANDA /
Application NumberANDA202099
Labeler NameJG Pharma Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength10 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 72143-231-30

3 BLISTER PACK in 1 CARTON (72143-231-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-231-10)
Marketing Start Date2021-01-11
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ACCUTANE" or generic name "Isotretinoin"

NDCBrand NameGeneric Name
10631-115Absoricaisotretinoin
10631-116Absoricaisotretinoin
10631-117Absoricaisotretinoin
10631-118Absoricaisotretinoin
10631-133Absoricaisotretinoin
10631-134Absoricaisotretinoin
10631-002Absorica LDisotretinoin
10631-003Absorica LDisotretinoin
10631-004Absorica LDisotretinoin
10631-005Absorica LDisotretinoin
10631-006Absorica LDisotretinoin
10631-007Absorica LDisotretinoin
0378-6611Amnesteemisotretinoin
0378-6612Amnesteemisotretinoin
0378-6614Amnesteemisotretinoin
0555-1054ClaravisIsotretinoin
0555-1055ClaravisIsotretinoin
0555-1056ClaravisIsotretinoin
0555-1057ClaravisIsotretinoin

Trademark Results [ACCUTANE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUTANE
ACCUTANE
87003385 5788124 Live/Registered
T.BERRY BIOTECH, LLC
2016-04-16
ACCUTANE
ACCUTANE
72443249 0966924 Dead/Cancelled
HOFFMANN-LA ROCHE INC.
1972-12-08

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.