Details for New Drug Application (NDA): 075945
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NDA 075945 describes AMNESTEEM, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the AMNESTEEM profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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