Details for New Drug Application (NDA): 218158
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The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 218158
Tradename: | CLOBETASOL PROPIONATE |
Applicant: | Formosa |
Ingredient: | clobetasol propionate |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 218158
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Mar 4, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 4, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF INFLAMMATION |
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