Details for New Drug Application (NDA): 091489
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NDA 091489 describes ATRACURIUM BESYLATE, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Norvium Bioscience, Teva Parenteral, Watson Pharms Teva, and Watson Labs Inc, and is included in twenty-two NDAs. It is available from three suppliers. Additional details are available on the ATRACURIUM BESYLATE profile page.
The generic ingredient in ATRACURIUM BESYLATE 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 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 091489
| Tradename: | ATRACURIUM BESYLATE |
| Applicant: | Meitheal |
| Ingredient: | atracurium besylate |
| Patents: | 0 |
Pharmacology for NDA: 091489
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Medical Subject Heading (MeSH) Categories for 091489
Suppliers and Packaging for NDA: 091489
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATRACURIUM BESYLATE | atracurium besylate | INJECTABLE;INJECTION | 091489 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-702 | 71288-702-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (71288-702-10) / 10 mL in 1 VIAL, MULTI-DOSE (71288-702-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Feb 17, 2012 | TE: | AP | RLD: | No | ||||
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