CDER New July 18, 2017

What's New on the FDA Drugs Site

July 17, 2017

• FDA Medication Guides Page (Updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Draft Agenda for Hatch-Waxman Amendent Public Meeting, July 18, 2017 (PDF 58 KB)
• Drugs@FDA Data Files (updated)
• Public Notifications:
  • RHINO 7 Platinum 5000 contains hidden drug ingredient
  • Royal Honey VIP contains hidden drug ingredient
  • Kingdom Honey for Him contains hidden drug ingredient
  • Kingdom Honey for Her contains hidden drug ingredient
• Manual of Policies and Procedures (MAPP) 4520.1Rev.2 Communicating Drug Approval Information (PDF - 614KB)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

---

New and Generic Drug Approvals

July 17, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Choline C-11 ANDA #205690	Choline C-11	Injectable; Intravenous	SUPPL-2	Univ Tx Md Anderson	Manufacturing (CMC)	Approved
Choline C-11 ANDA #205690	Choline C-11	Injectable; Intravenous	SUPPL-2	Univ Tx Md Anderson	Manufacturing (CMC)	Approved
Midozalam Hydrochloride ANDA #090316	Midazolam Hydrochloride	Injectable; Injection	SUPPL-9	Sagent Strides	Labeling	Approved
Nerlynx NDA #208051	Neratinib Maleate	Tablet; Oral	ORIG-1	Puma Biotech Inc	Labeling	Approved

July 14, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-3	Lupin Ltd	Manufacturing (CMC)	Approved
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-2	Lupin Ltd	Labeling	Approved
Armodafinil ANDA #200751	Armodafinil	Tablet; Oral	SUPPL-3	Lupin Ltd	Manufacturing (CMC)	Approved
Bevyxxa NDA #208383	Betrixaban	Capsule; Oral	SUPPL-1	Portola Pharms Inc	Labeling	Approved
Emsam NDA #021336	Selegiline	Film, Extended Release; Transdermal	SUPPL-14	Somerset	Labeling	Approved
Furosemide NDA #018823	Furosemide	Tablet; Oral	SUPPL-44	West-Ward Pharms Int	Labeling	Approved
Methylphenidate Hydrochloride ANDA #208607	Methylphenidate Hydrochloride	Tablet, Extended Release; Oral	ORIG-1	Impax Labs Inc		Approved
Nallpen In Plastic Container NDA #050655	Nafcillin Sodium	Injectable; Injection	SUPPL-25	Baxter Hlthcare	Labeling	Approved
Paroxetine Hydrochloride ANDA #078194	Paroxetine Hydrochloride	Tablet; Oral	SUPPL-12	Sun Pharm Inds Inc	Manufacturing (CMC)	Approved
Paroxetine Hydrochloride ANDA #078194	Paroxetine Hydrochloride	Tablet; Oral	SUPPL-14	Sun Pharm Inds Inc	Labeling	Approved
Paroxetine Hydrochloride ANDA #078194	Paroxetine Hydrochloride	Tablet; Oral	SUPPL-13	Sun Pharm Inds Inc	Labeling	Approved
Paroxetine Hydrochloride ANDA #078194	Paroxetine Hydrochloride	Tablet; Oral	SUPPL-14	Sun Pharm Inds Inc	Labeling	Approved
Paroxetine Hydrochloride ANDA #078194	Paroxetine Hydrochloride	Tablet; Oral	SUPPL-12	Sun Pharm Inds Inc	Manufacturing (CMC)	Approved
Phentolamine Mesylate ANDA #207686	Phentolamine Mesylate	Injectable; Injection	ORIG-1	Precision Dose Inc		Approved
Xulane ANDA #200910	Ethinyl Estradiol; Norelgestromin	Film, Extended Release; Transdermal	SUPPL-1	Mylan Technologies	Labeling	Approved
Xulane ANDA #200910	Ethinyl Estradiol; Norelgestromin	Film, Extended Release; Transdermal	SUPPL-3	Mylan Technologies	Labeling	Approved
Xulane ANDA #200910	Ethinyl Estradiol; Norelgestromin	Film, Extended Release; Transdermal	SUPPL-3	Mylan Technologies	Labeling	Approved
Zypitamag NDA #208379	Pitavastatin	Tablet; Oral	ORIG-1	Zydus Pharms Usa Inc	Type 2 - New Active Ingredient	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 18, 2017 — 2 Comments