Details for New Drug Application (NDA): 074413
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NDA 074413 describes SUFENTANIL CITRATE, which is a drug marketed by Hikma, Hospira, and Watson Labs, and is included in three NDAs. It is available from two suppliers. Additional details are available on the SUFENTANIL CITRATE profile page.
The generic ingredient in SUFENTANIL CITRATE is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
The generic ingredient in SUFENTANIL CITRATE is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
Summary for 074413
| Tradename: | SUFENTANIL CITRATE |
| Applicant: | Hikma |
| Ingredient: | sufentanil citrate |
| Patents: | 0 |
Pharmacology for NDA: 074413
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 074413
Suppliers and Packaging for NDA: 074413
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUFENTANIL CITRATE | sufentanil citrate | INJECTABLE;INJECTION | 074413 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6110 | 0641-6110-10 | 10 AMPULE in 1 CARTON (0641-6110-10) / 1 mL in 1 AMPULE (0641-6110-01) |
| SUFENTANIL CITRATE | sufentanil citrate | INJECTABLE;INJECTION | 074413 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6111 | 0641-6111-10 | 10 AMPULE in 1 CARTON (0641-6111-10) / 2 mL in 1 AMPULE (0641-6111-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Dec 15, 1995 | TE: | AP | RLD: | No | ||||
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