Details for New Drug Application (NDA): 209655
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NDA 209655 describes FENTANYL-87, which is a drug marketed by Difgen Pharms, Mylan Technologies, and Zydus Pharms, and is included in three NDAs. It is available from five suppliers. Additional details are available on the FENTANYL-87 profile page.
The generic ingredient in FENTANYL-87 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
The generic ingredient in FENTANYL-87 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 209655
| Tradename: | FENTANYL-87 |
| Applicant: | Zydus Pharms |
| Ingredient: | fentanyl |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 209655
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 12.5MCG/HR | ||||
| Approval Date: | Jan 24, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 25MCG/HR | ||||
| Approval Date: | Jan 24, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 37.5MCG/HR | ||||
| Approval Date: | Jan 24, 2023 | TE: | RLD: | No | |||||
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