Details for New Drug Application (NDA): 076041
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NDA 076041 describes SOTRET, which is a drug marketed by Sun Pharm Inds Ltd and is included in two NDAs. Additional details are available on the SOTRET profile page.
The generic ingredient in SOTRET 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 SOTRET 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 076041
| Tradename: | SOTRET |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | isotretinoin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076041
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Dec 24, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 24, 2002 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Dec 24, 2002 | TE: | RLD: | No | |||||
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