Details for New Drug Application (NDA): 202097
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NDA 202097 describes FENTANYL-75, which is a drug marketed by Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FENTANYL-75 profile page.
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.
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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