Details for New Drug Application (NDA): 008845
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NDA 008845 describes QUELICIN PRESERVATIVE FREE, which is a drug marketed by Hospira and is included in one NDA. It is available from three suppliers. Additional details are available on the QUELICIN PRESERVATIVE FREE profile page.
The generic ingredient in QUELICIN PRESERVATIVE FREE is succinylcholine chloride. There are six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the succinylcholine chloride profile page.
The generic ingredient in QUELICIN PRESERVATIVE FREE is succinylcholine chloride. There are six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the succinylcholine chloride profile page.
Summary for 008845
| Tradename: | QUELICIN PRESERVATIVE FREE |
| Applicant: | Hospira |
| Ingredient: | succinylcholine chloride |
| Patents: | 0 |
Pharmacology for NDA: 008845
| Physiological Effect | Neuromuscular Depolarizing Blockade |
Medical Subject Heading (MeSH) Categories for 008845
Suppliers and Packaging for NDA: 008845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QUELICIN | succinylcholine chloride | INJECTABLE;INJECTION | 008845 | NDA | Hospira, Inc. | 0409-6629 | 0409-6629-02 | 25 VIAL, MULTI-DOSE in 1 TRAY (0409-6629-02) / 10 mL in 1 VIAL, MULTI-DOSE (0409-6629-12) |
| QUELICIN | succinylcholine chloride | INJECTABLE;INJECTION | 008845 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1353 | 51662-1353-1 | 10 mL in 1 VIAL, MULTI-DOSE (51662-1353-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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