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Details for New Drug Application (NDA): 076135
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NDA 076135 describes CLARAVIS, which is a drug marketed by Teva Pharms Usa and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARAVIS profile page.
The generic ingredient in CLARAVIS is isotretinoin. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in CLARAVIS is isotretinoin. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 076135
| Tradename: | CLARAVIS |
| Applicant: | Teva Pharms Usa |
| Ingredient: | isotretinoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLARAVIS | isotretinoin | CAPSULE;ORAL | 076135 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-1055 | 0555-1055-56 | 10 BLISTER PACK in 1 CARTON (0555-1055-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60) |
| CLARAVIS | isotretinoin | CAPSULE;ORAL | 076135 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-1055 | 0555-1055-86 | 3 BLISTER PACK in 1 CARTON (0555-1055-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 11, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 11, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | May 11, 2006 | TE: | AB | RLD: | No | ||||
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