Details for New Drug Application (NDA): 215635
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NDA 215635 describes REMIFENTANIL HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Hikma, and Nivagen Pharms Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the REMIFENTANIL HYDROCHLORIDE profile page.
The generic ingredient in REMIFENTANIL HYDROCHLORIDE is remifentanil hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.
The generic ingredient in REMIFENTANIL HYDROCHLORIDE is remifentanil hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.
Summary for 215635
| Tradename: | REMIFENTANIL HYDROCHLORIDE |
| Applicant: | Nivagen Pharms Inc |
| Ingredient: | remifentanil hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215635
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 215635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 215635 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-230 | 75834-230-10 | 10 VIAL, GLASS in 1 CARTON (75834-230-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (75834-230-01) |
| REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 215635 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-231 | 75834-231-10 | 10 VIAL, GLASS in 1 CARTON (75834-231-10) / 2 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (75834-231-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2024 | TE: | AP | RLD: | No | ||||
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