Details for New Drug Application (NDA): 016619
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NDA 016619 describes SUBLIMAZE PRESERVATIVE FREE, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. Additional details are available on the SUBLIMAZE PRESERVATIVE FREE profile page.
The generic ingredient in SUBLIMAZE PRESERVATIVE FREE is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
The generic ingredient in SUBLIMAZE PRESERVATIVE FREE is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 016619
| Tradename: | SUBLIMAZE PRESERVATIVE FREE |
| Applicant: | Akorn |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 016619
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 016619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUBLIMAZE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 016619 | NDA | Akorn | 17478-030 | 17478-030-02 | 10 AMPULE in 1 CARTON (17478-030-02) / 2 mL in 1 AMPULE |
| SUBLIMAZE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 016619 | NDA | Akorn | 17478-030 | 17478-030-05 | 10 AMPULE in 1 CARTON (17478-030-05) / 5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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