Details for New Drug Application (NDA): 076485
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NDA 076485 describes MYORISAN, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the MYORISAN profile page.
The generic ingredient in MYORISAN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in MYORISAN is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 076485
| Tradename: | MYORISAN |
| Applicant: | Upsher Smith Labs |
| Ingredient: | isotretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYORISAN | isotretinoin | CAPSULE;ORAL | 076485 | ANDA | Upsher-Smith Laboratories, LLC | 0832-8301 | 0832-8301-30 | 3 BLISTER PACK in 1 BOX (0832-8301-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8301-89) |
| MYORISAN | isotretinoin | CAPSULE;ORAL | 076485 | ANDA | Upsher-Smith Laboratories, LLC | 0832-8302 | 0832-8302-30 | 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | AB1 | RLD: | No | ||||
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