Details for New Drug Application (NDA): 218194
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The generic ingredient in ISOTRETINOIN 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 218194
Tradename: | ISOTRETINOIN |
Applicant: | Aurobindo Pharma |
Ingredient: | isotretinoin |
Patents: | 0 |
Suppliers and Packaging for NDA: 218194
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 218194 | ANDA | Aurobindo Pharma Limited | 59651-631 | 59651-631-03 | 3 BLISTER PACK in 1 CARTON (59651-631-03) / 10 CAPSULE in 1 BLISTER PACK |
ISOTRETINOIN | isotretinoin | CAPSULE;ORAL | 218194 | ANDA | Aurobindo Pharma Limited | 59651-632 | 59651-632-03 | 3 BLISTER PACK in 1 CARTON (59651-632-03) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 29, 2024 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
Approval Date: | Jan 29, 2024 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Jan 29, 2024 | TE: | AB2 | RLD: | No |
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