CDER New January 23, 2016

What's New on the FDA Drugs Site

 

January 19, 2017

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• FDA Drug Shortages
  • Nitrous Oxide, Gas (Updated - Currently in Shortage)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

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New and Generic Drug Approvals

January 18, 2017

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Submission	Company	Submission Classification	Submission Status
Aspirin and Dipyridamole ANDA #206739	Aspirin; Dipyridamole	Capsule, Extended Release; Oral	ORIG-1	Sandoz Inc		Approved
Benlysta BLA #125370	Belimumab	Injectable; Injection	SUPPL-57	Human Genome Sciences Inc.	LABELING	Approved
Clindesse NDA #050793	Clindamycin Phosphate	Cream; Vaginal	SUPPL-22	Perrigo Pharma Intl	MANUF (CMC)	Approved
Imbruvica NDA #205552	Ibrutinib	Capsule; Oral	SUPPL-16	Pharmacyclics Inc	EFFICACY	Approved
Janumet NDA #022044	Metformin Hydrochloride; Sitagliptin Phosphate	Tablet; Oral	SUPPL-39	Merck Sharp Dohme	LABELING	Approved
Janumet NDA #022044	Metformin Hydrochloride; Sitagliptin Phosphate	Tablet; Oral	SUPPL-40	Merck Sharp Dohme	LABELING	Approved
Janumet Xr NDA #202270	Metformin Hydrochloride; Sitagliptin Phosphate	Tablet, Extended Release; Oral	SUPPL-15	Merck Sharp Dohme	LABELING	Approved
Janumet Xr NDA #202270	Metformin Hydrochloride; Sitagliptin Phosphate	Tablet, Extended Release; Oral	SUPPL-16	Merck Sharp Dohme	LABELING	Approved
Januvia NDA #021995	Sitagliptin Phosphate	Tablet; Oral	SUPPL-38	Merck Sharp Dohme	LABELING	Approved
Kombiglyze Xr NDA #200678	Metformin Hydrochloride; Saxagliptin Hydrochloride	Tablet, Extended Release; Oral	SUPPL-19	Astrazeneca Ab	LABELING	Approved
Kombiglyze Xr NDA #200678	Metformin Hydrochloride; Saxagliptin Hydrochloride	Tablet, Extended Release; Oral	SUPPL-20	Astrazeneca Ab	LABELING	Approved
Onglyza NDA #022350	Saxagliptin Hydrochloride	Tablet; Oral	SUPPL-19	Astrazeneca Ab	LABELING	Approved
Quetiapine Fumarate ANDA #206252	Quetiapine Fumarate	Tablet, Extended Release; Oral	ORIG-1	Accord Hlthcare Inc		Tentative Approval

 

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— Monday, January 23, 2017 — Add Comment