Details for New Drug Application (NDA): 091019
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NDA 091019 describes CHENODIOL, which is a drug marketed by Lgm Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the CHENODIOL profile page.
The generic ingredient in CHENODIOL is chenodiol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chenodiol profile page.
The generic ingredient in CHENODIOL is chenodiol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chenodiol profile page.
Summary for 091019
| Tradename: | CHENODIOL |
| Applicant: | Lgm Pharma |
| Ingredient: | chenodiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHENODIOL | chenodiol | TABLET;ORAL | 091019 | ANDA | Travere Therapeutics | 68974-876 | 68974-876-40 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68974-876-40) |
| CHENODIOL | chenodiol | TABLET;ORAL | 091019 | ANDA | LGM PHARMA SOLUTIONS, LLC | 79739-7121 | 79739-7121-1 | 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79739-7121-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Oct 22, 2009 | TE: | RLD: | No | |||||
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