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Details for New Drug Application (NDA): 076135
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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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