Details for New Drug Application (NDA): 209564
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NDA 209564 describes LINACLOTIDE, which is a drug marketed by Aurobindo Pharma and Mylan and is included in two NDAs. Additional details are available on the LINACLOTIDE profile page.
The generic ingredient in LINACLOTIDE is linaclotide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the linaclotide profile page.
The generic ingredient in LINACLOTIDE is linaclotide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the linaclotide profile page.
Summary for 209564
| Tradename: | LINACLOTIDE |
| Applicant: | Mylan |
| Ingredient: | linaclotide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 145MCG | ||||
| Approval Date: | Feb 9, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 290MCG | ||||
| Approval Date: | Feb 9, 2021 | TE: | RLD: | No | |||||
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