Details for New Drug Application (NDA): 076503
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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 076503
Tradename: | SOTRET |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | isotretinoin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 076503
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Jun 20, 2003 | TE: | RLD: | No |
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