Details for New Drug Application (NDA): 206010
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NDA 206010 describes ATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Norvium Bioscience, and Watson Labs Inc, and is included in eleven NDAs. It is available from three suppliers. Additional details are available on the ATRACURIUM BESYLATE PRESERVATIVE FREE profile page.
The generic ingredient in ATRACURIUM BESYLATE PRESERVATIVE FREE is atracurium besylate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
The generic ingredient in ATRACURIUM BESYLATE PRESERVATIVE FREE is atracurium besylate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
Summary for 206010
| Tradename: | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| Applicant: | Eugia Pharma |
| Ingredient: | atracurium besylate |
| Patents: | 0 |
Pharmacology for NDA: 206010
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Medical Subject Heading (MeSH) Categories for 206010
Suppliers and Packaging for NDA: 206010
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATRACURIUM BESYLATE PRESERVATIVE FREE | atracurium besylate | INJECTABLE;INJECTION | 206010 | ANDA | AuroMedics Pharma LLC | 55150-216 | 55150-216-05 | 10 VIAL, SINGLE-USE in 1 CARTON (55150-216-05) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Apr 8, 2015 | TE: | AP | RLD: | No | ||||
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