Details for New Drug Application (NDA): 075945
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The generic ingredient in AMNESTEEM 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 075945
Tradename: | AMNESTEEM |
Applicant: | Mylan Pharms Inc |
Ingredient: | isotretinoin |
Patents: | 0 |
Suppliers and Packaging for NDA: 075945
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6611 | 0378-6611-93 | 3 BLISTER PACK in 1 CARTON (0378-6611-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6611-85) |
AMNESTEEM | isotretinoin | CAPSULE;ORAL | 075945 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6612 | 0378-6612-93 | 3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6612-85) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 8, 2002 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Nov 8, 2002 | TE: | AB1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
Approval Date: | Nov 8, 2002 | TE: | AB1 | RLD: | No |
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