Details for New Drug Application (NDA): 216003
NDA 216003 describes SUCCINYLCHOLINE CHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal, Amphastar Pharms Inc, Aspiro, Baxter Hlthcare Corp, Be Pharms, Breckenridge, Deva Holding As, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Intl Medication, J Molner, Mankind Pharma, Meitheal, Micro Labs, Nexus, Nivagen, Organon Usa Inc, Regcon Holdings, Sagent Pharms Inc, Somerset Theraps Llc, Zydus Pharms, and Steriscience, and is included in thirty NDAs. It is available from twenty-five suppliers. There is one patent protecting this drug. Additional details are available on the SUCCINYLCHOLINE CHLORIDE profile page.
The generic ingredient in SUCCINYLCHOLINE CHLORIDE is succinylcholine chloride. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the succinylcholine chloride profile page.
The generic ingredient in SUCCINYLCHOLINE CHLORIDE is succinylcholine chloride. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the succinylcholine chloride profile page.
Summary for 216003
| Tradename: | SUCCINYLCHOLINE CHLORIDE |
| Applicant: | Be Pharms |
| Ingredient: | succinylcholine chloride |
| Patents: | 0 |
Pharmacology for NDA: 216003
| Physiological Effect | Neuromuscular Depolarizing Blockade |
Medical Subject Heading (MeSH) Categories for 216003
Suppliers and Packaging for NDA: 216003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUCCINYLCHOLINE CHLORIDE | succinylcholine chloride | INJECTABLE;INJECTION | 216003 | ANDA | Nordic Pharma, Inc. | 69918-700 | 69918-700-12 | 10 VIAL, MULTI-DOSE in 1 CARTON (69918-700-12) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) |
| SUCCINYLCHOLINE CHLORIDE | succinylcholine chloride | INJECTABLE;INJECTION | 216003 | ANDA | Nordic Pharma, Inc. | 69918-700 | 69918-700-29 | 25 VIAL, MULTI-DOSE in 1 CARTON (69918-700-29) / 10 mL in 1 VIAL, MULTI-DOSE (69918-700-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Feb 7, 2022 | TE: | AP | RLD: | No | ||||
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