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 | 72143-232_59a3c0bb-8c7f-4a86-96f0-43d85fe6c0a4 |
| NDC | 72143-232 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ACCUTANE |
| Generic Name | Isotretinoin |
| Dosage Form | Capsule, Gelatin Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-01-11 |
| Marketing End Date | 2023-11-30 |
| Marketing Category | ANDA / 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 |
| Marketing Start Date | 2021-01-11 |
| Marketing End Date | 2023-11-30 |
| 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 |