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 ID | 72143-252_78f92a10-c27d-4238-8dc5-771a69c29119 |
NDC | 72143-252 |
Product Type | Human Prescription Drug |
Proprietary Name | ACCUTANE |
Generic Name | Isotretinoin |
Dosage Form | Capsule, Gelatin Coated |
Route of Administration | ORAL |
Marketing Start Date | 2022-08-01 |
Marketing Category | ANDA / |
Application Number | ANDA202099 |
Labeler Name | JG Pharma Inc. |
Substance Name | ISOTRETINOIN |
Active Ingredient Strength | 20 mg/1 |
Pharm Classes | Retinoid [EPC], Retinoids [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2022-08-01 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
72143-232 | ACCUTANE | ACCUTANE |
72143-233 | ACCUTANE | ACCUTANE |
72143-234 | ACCUTANE | ACCUTANE |
72143-231 | ACCUTANE | ACCUTANE |
0378-6611 | Amnesteem | isotretinoin |
0378-6612 | Amnesteem | isotretinoin |
0378-6614 | Amnesteem | isotretinoin |
0555-1054 | Claravis | Isotretinoin |
0555-1055 | Claravis | Isotretinoin |
0555-1056 | Claravis | Isotretinoin |
0555-1057 | Claravis | Isotretinoin |
0245-0570 | Isotretinoin | Isotretinoin |
0245-0571 | Isotretinoin | Isotretinoin |
0245-0573 | Isotretinoin | Isotretinoin |
0245-0575 | Isotretinoin | Isotretinoin |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCUTANE 87003385 5788124 Live/Registered |
T.BERRY BIOTECH, LLC 2016-04-16 |
ACCUTANE 72443249 0966924 Dead/Cancelled |
HOFFMANN-LA ROCHE INC. 1972-12-08 |