Details for New Drug Application (NDA): 204960
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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 204960
Tradename: | CISATRACURIUM BESYLATE PRESERVATIVE FREE |
Applicant: | Hengrui Pharma |
Ingredient: | cisatracurium besylate |
Patents: | 0 |
Pharmacology for NDA: 204960
Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Suppliers and Packaging for NDA: 204960
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 204960 | ANDA | Teva Parenteral Medicines, Inc. | 0703-2033 | 0703-2033-03 | 10 CARTON in 1 BOX (0703-2033-03) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | cisatracurium besylate | INJECTABLE;INJECTION | 204960 | ANDA | Teva Parenteral Medicines, Inc. | 0703-2045 | 0703-2045-03 | 10 CARTON in 1 BOX (0703-2045-03) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 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: | Jan 27, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
Approval Date: | Sep 19, 2017 | TE: | AP | RLD: | No |
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