Details for New Drug Application (NDA): 216539
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NDA 216539 describes CISATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Sandoz Inc, and Somerset Theraps Llc, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the CISATRACURIUM BESYLATE PRESERVATIVE FREE profile page.
The generic ingredient in CISATRACURIUM BESYLATE PRESERVATIVE FREE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
The generic ingredient in CISATRACURIUM BESYLATE PRESERVATIVE FREE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 216539
| Tradename: | CISATRACURIUM BESYLATE PRESERVATIVE FREE |
| Applicant: | Hainan Poly |
| Ingredient: | cisatracurium besylate |
| Patents: | 0 |
Pharmacology for NDA: 216539
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 216539
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 216539 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-112 | 70436-112-82 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-112-82) / 5 mL in 1 VIAL, SINGLE-DOSE |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 216539 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-114 | 70436-114-82 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-114-82) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Aug 27, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Aug 27, 2024 | TE: | AP | RLD: | No | ||||
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