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Details for New Drug Application (NDA): 205880

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NDA 205880 describes SODIUM PHENYLACETATE AND SODIUM BENZOATE, which is a drug marketed by Navinta Llc and Ailex Pharms Pvt Ltd and is included in two NDAs. It is available from two suppliers. Additional details are available on the SODIUM PHENYLACETATE AND SODIUM BENZOATE profile page.

The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE is sodium benzoate; sodium phenylacetate. There are one thousand three hundred and twenty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.

Summary for NDA: 205880

Navinta Llc
sodium benzoate; sodium phenylacetate
Formulation / Manufacturing:see details

Pharmacology for NDA: 205880

Mechanism of ActionAmmonium Ion Binding Activity

Suppliers and Packaging for NDA: 205880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium benzoate; sodium phenylacetate
SOLUTION;IV (INFUSION) 205880 ANDA Zydus Pharmaceuticals USA Inc. 68382-396 68382-396-01 1 VIAL in 1 CARTON (68382-396-01) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10%;10% (5GM/50ML;5GM/50ML)
Approval Date:Aug 4, 2016TE:APRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.