CDER New July 11, 2017

What's New on the FDA Drugs Site

July 10, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

---

New and Generic Drug Approvals

July 10, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Avalide NDA #020758	Hydrochlorothiazide; Irbesartan	Tablet; Oral	SUPPL-72	Sanofi Aventis Us	Labeling	Approved
Plavix NDA #020839	Clopidogrel Bisulfate	Tablet; Oral	SUPPL-67	Sanofi Aventis Us	Labeling	Approved
Plavix NDA #020839	Clopidogrel Bisulfate	Tablet; Oral	SUPPL-67	Sanofi Aventis Us	Labeling	Approved
Xyzal NDA #022064	Levocetirizine Dihydrochloride	Tablet; Oral	SUPPL-33	Ucb Inc	Labeling	Approved
Xyzal NDA #022157	Levocetirizine Dihydrochloride	Solution; Oral	SUPPL-16	Ucb Inc	Labeling	Approved

July 7, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Busulfan ANDA #205106	Busulfan	Injectable; Injection	ORIG-1	Sandoz Inc		Approved
Dabigatran Etexilate ANDA #208046	Dabigatran Etexilate	Capsule; Oral	ORIG-1	Alembic Pharms Ltd		Tentative Approval
Doxazosin Mesylate ANDA #208719	Doxazosin Mesylate	Tablet; Oral	ORIG-1	Zydus Pharms Usa Inc		Approved
Endari NDA #208587	L-Glutamine	Powder; Oral	ORIG-1	Emmaus Medcl	Type 5 - New Formulation or New Manufacturer	Approved
Flucytosine ANDA #204652	Flucytosine	Capsule; Oral	ORIG-1	Novel Labs Inc		Approved
Levoleucovorin ANDA #207548	Levoleucovorin	Injectable; Injection	ORIG-1	Amneal Pharms Co		Tentative Approval
Linezolid ANDA #207001	Linezolid	Solution; Iv (Infusion)	ORIG-1	Hq Spclt Pharma		Approved
Liquid E-Z-Paque NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Lurasidone Hydrochloride ANDA #208052	Lurasidone Hydrochloride	Tablet; Oral	ORIG-1	Zydus Pharms Usa		Tentative Approval
Octreotide Acetate (Preservative Free) ANDA #079198	Octreotide Acetate	Injectable; Injection	SUPPL-5	Mylan Institutional	Labeling	Approved
Octreotide Acetate (Preservative Free) ANDA #079198	Octreotide Acetate	Injectable; Injection	SUPPL-6	Mylan Institutional	Labeling	Approved
Octreotide Acetate (Preservative Free) ANDA #079198	Octreotide Acetate	Injectable; Injection	SUPPL-5	Mylan Institutional	Labeling	Approved
Octreotide Acetate (Preservative Free) ANDA #079198	Octreotide Acetate	Injectable; Injection	SUPPL-6	Mylan Institutional	Labeling	Approved
Pravastatin Sodium ANDA #076341	Pravastatin Sodium	Tablet; Oral	SUPPL-19	Apotex Inc	Labeling	Approved
Pravastatin Sodium ANDA #076341	Pravastatin Sodium	Tablet; Oral	SUPPL-19	Apotex Inc	Labeling	Approved
Readi-Cat 2 NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Readi-Cat 2 Smoothies NDA #208143	Barium Sulfate	Suspension; Oral	SUPPL-4	Bracco	Efficacy	Approved
Reclast NDA #021817	Zoledronic Acid	Injectable; Iv (Infusion)	SUPPL-27	Novartis	Labeling	Approved
Tetrabenazine ANDA #206686	Tetrabenazine	Tablet; Oral	ORIG-1	Actavis Labs Fl Inc		Approved
Travoprost ANDA #205050	Travoprost	Solution/Drops; Ophthalmic	ORIG-1	Mylan Pharms Inc		Approved

 

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

 

---

This email was sent to rssproject471@gmail.com using GovDelivery Communications Cloud on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)

Tweet

Postingan terkait:

— Tuesday, July 11, 2017 — Add Comment