Skip to contentApplication 205063
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 10MG | No | No |
| 002 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 20MG | No | No |
| 003 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 25MG | No | No |
| 004 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 30MG | No | No |
| 005 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 35MG | No | No |
| 006 | ISOTRETINOIN | ISOTRETINOIN | CAPSULE;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2433 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2434 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2435 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2436 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2451 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2501 | Isotretinoin | Isotretinoin | Actavis Pharma, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76354 | ORIG | 2023-11-06 |