Details for New Drug Application (NDA): 215516
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NDA 215516 describes CISATRACURIUM BESYLATE, which is a drug marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, and Somerset Theraps Llc, and is included in twenty-six NDAs. It is available from fourteen suppliers. Additional details are available on the CISATRACURIUM BESYLATE profile page.
The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.
Summary for 215516
| Tradename: | CISATRACURIUM BESYLATE |
| Applicant: | Gland |
| Ingredient: | cisatracurium besylate |
| Patents: | 0 |
Pharmacology for NDA: 215516
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 215516
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 215516 | ANDA | Gland Pharma Limited | 68083-486 | 68083-486-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-486-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
| CISATRACURIUM BESYLATE | cisatracurium besylate | INJECTABLE;INJECTION | 215516 | ANDA | Gland Pharma Limited | 68083-487 | 68083-487-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-487-01) / 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: | May 24, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | May 24, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2MG BASE/ML | ||||
| Approval Date: | Dec 14, 2022 | TE: | AP | RLD: | No | ||||
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