Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Kindeva Drug Delivery L.P.
117492677
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Kindeva Drug Delivery L.P.
ALVOGEN
Kindeva Drug Delivery L.P.
128688199
Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl system
Product Details
NDC Product Code
47781-427Application Number
ANDA202097Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 18, 2024METHYL LAURATEInactive
Code: 8IPS6BI6KWClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 1
Fentanyl system
Product Details
NDC Product Code
47781-428Application Number
ANDA202097Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 18, 2024METHYL LAURATEInactive
Code: 8IPS6BI6KWClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 100 ug in 1 1
Fentanyl system
Product Details
NDC Product Code
47781-424Application Number
ANDA202097Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 18, 2024FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 1
METHYL LAURATEInactive
Code: 8IPS6BI6KWClass: IACT
Fentanyl system
Product Details
NDC Product Code
47781-423Application Number
ANDA202097Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 18, 2024METHYL LAURATEInactive
Code: 8IPS6BI6KWClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 12.5 ug in 1 1
Fentanyl system
Product Details
NDC Product Code
47781-426Application Number
ANDA202097Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 18, 2024METHYL LAURATEInactive
Code: 8IPS6BI6KWClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 50 ug in 1 1