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Generated: March 19, 2019

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Details for New Drug Application (NDA): 208690

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NDA 208690 describes DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, and Somerset Theraps Llc, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE profile page.

The generic ingredient in DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
Summary for 208690
Applicant:Amneal Pharms Co
Ingredient:dexamethasone sodium phosphate
Formulation / Manufacturing:see details
Pharmacology for NDA: 208690
Suppliers and Packaging for NDA: 208690
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE dexamethasone sodium phosphate INJECTABLE;INJECTION 208690 ANDA Amneal Biosciences LLC 70121-1399 70121-1399-5 25 VIAL in 1 CARTON (70121-1399-5) > 1 mL in 1 VIAL (70121-1399-1)

Profile for product number 001

Approval Date:Aug 22, 2018TE:APRLD:No

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