Details for New Drug Application (NDA): 202097
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The generic ingredient in FENTANYL-75 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 202097
Tradename: | FENTANYL-75 |
Applicant: | Kindeva |
Ingredient: | fentanyl |
Patents: | 0 |
Pharmacology for NDA: 202097
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 202097
Suppliers and Packaging for NDA: 202097
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 202097 | ANDA | ALVOGEN | 47781-423 | 47781-423-47 | 5 POUCH in 1 CARTON (47781-423-47) / 1 PATCH in 1 POUCH (47781-423-11) |
FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 202097 | ANDA | ALVOGEN | 47781-424 | 47781-424-47 | 5 POUCH in 1 CARTON (47781-424-47) / 1 PATCH in 1 POUCH (47781-424-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 12.5MCG/HR | ||||
Approval Date: | Nov 4, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 25MCG/HR | ||||
Approval Date: | Nov 4, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 50MCG/HR | ||||
Approval Date: | Nov 4, 2016 | TE: | AB | RLD: | No |
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