Details for New Drug Application (NDA): 210762
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NDA 210762 describes FENTANYL CITRATE PRESERVATIVE FREE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, and Hospira, and is included in three NDAs. It is available from one supplier. Additional details are available on the FENTANYL CITRATE PRESERVATIVE FREE profile page.
The generic ingredient in FENTANYL CITRATE 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 FENTANYL CITRATE 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 210762
| Tradename: | FENTANYL CITRATE PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | fentanyl citrate |
| Patents: | 0 |
Pharmacology for NDA: 210762
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 210762
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENTANYL CITRATE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 210762 | ANDA | Fresenius Kabi USA, LLC | 63323-806 | 63323-806-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11) |
| FENTANYL CITRATE PRESERVATIVE FREE | fentanyl citrate | INJECTABLE;INJECTION | 210762 | ANDA | Fresenius Kabi USA, LLC | 63323-806 | 63323-806-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | May 3, 2019 | TE: | AP | RLD: | No | ||||
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