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What's New on the FDA Drugs Site

February 10, 2017

• Medication Guides (updated)
• Drug Trials Snapshot: PARSABIV
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
•  Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA) (updated)

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New and Generic Drug Approvals

February 10, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Oxaliplatin  ANDA #207325	Oxaliplatin	Injectable; Iv (Infusion)	ORIG-1	Gland Pharma Ltd		Approved
Zithromax  NDA #050710	Azithromycin	For Suspension; Oral	SUPPL-44	Pfizer	LABELING	Approved
Zithromax  NDA #050711	Azithromycin	Tablet; Oral	SUPPL-41	Pfizer	LABELING	Approved
Zithromax  NDA #050733	Azithromycin	Injectable; Injection	SUPPL-43	Pfizer	LABELING	Approved
Zithromax  NDA #050784	Azithromycin	Tablet; Oral	SUPPL-28	Pfizer	LABELING	Approved