Details for New Drug Application (NDA): 211843
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NDA 211843 describes THIOLA EC, which is a drug marketed by Mission Pharmacal and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the THIOLA EC profile page.
The generic ingredient in THIOLA EC is tiopronin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
The generic ingredient in THIOLA EC is tiopronin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
Summary for 211843
| Tradename: | THIOLA EC |
| Applicant: | Mission Pharmacal |
| Ingredient: | tiopronin |
| Patents: | 1 |
Pharmacology for NDA: 211843
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 211843
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA | Mission Pharmacal Company | 0178-0901 | 0178-0901-90 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90) |
| THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA | Mission Pharmacal Company | 0178-0902 | 0178-0902-01 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 28, 2019 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Patent: | 11,458,104 | Patent Expiration: | Nov 14, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING CYSTINURIA BY ORALLY ADMINISTERING TIOPRONIN WITH FOOD TO PREVENT CYSTINE STONE FORMATION IN ADULTS AND PEDIATRIC PATIENTS WITH SEVERE HOMOZYGOUS CYSTINURIA | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jun 28, 2019 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jun 28, 2026 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
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