Details for New Drug Application (NDA): 091488
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NDA 091488 describes ATRACURIUM BESYLATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Pharmobedient, 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 is one drug master file entry 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
Summary for 091488
| Tradename: | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| Applicant: | Meitheal |
| Ingredient: | atracurium besylate |
| Patents: | 0 |
Pharmacology for NDA: 091488
| Physiological Effect | Neuromuscular Nondepolarizing Blockade |
Medical Subject Heading (MeSH) Categories for 091488
Suppliers and Packaging for NDA: 091488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATRACURIUM BESYLATE PRESERVATIVE FREE | atracurium besylate | INJECTABLE;INJECTION | 091488 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-701 | 71288-701-05 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) |
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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