New Paragraph IV Certifications as of July 31, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Abiraterone Acetate Tablets 125 mg Yonsa; 210308 7/23/2018 Bendamustine Hydro...
Showing posts with label FDA Updates. Show all posts
Showing posts with label FDA Updates. Show all posts
New Paragraph IV Certifications as of July 03, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Tiotropium Bromide Inhalation Powder Capsules 18 mcg Spiriva; 21395 5/11/2018 ...
New Paragraph IV Certifications as of Jun 14, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Levocetirizine Dihydrochloride Oral Solution 0.5 mg/mL Xyzal Allergy 24 HR (OTC...
New Paragraph IV Certifications as of May 22, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Apremilast Tablets 10 mg, 20 mg and 30 mg Otezla, 205437 3/22/2018 Linaglipti...
New Paragraph IV Certifications as of April 25, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Vasopressin Injection 20 units/mL, 1 mL Vasostrict , 204485 3/23/2018 Clic...
New Paragraph IV Certifications as of April 17, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Axitinib Tablets 1 mg and 5 mg Inlyta, 202324 2/23/2018 Betamethasone Dipro...
New Paragraph IV Certifications as of March 27, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Halobetasol Propionate New Lotion 0.05% Ultavate, 208183 1/24/2018 Pregabal...
First in Vitro Diagnostic Blood Test for the evaluation of mTBI
Basic Information: On February 14, 2018 , The U.S. Food and Drug Administration (US FDA) permitted marketing of the first blood test ...
New Paragraph IV Certifications as of March 13, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Dapagliflozin Tablets 5 mg and 10 mg Farxiga, 202293 1/8/2018 Metformin Hydro...
New Paragraph IV Certifications as of February 28, 2018
DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION Dapagliflozin and Saxagliptan Tablets 10 mg/5 mg Qtern, 209091 1/8/2018 Ib...
FDA Drug Approval Statistics - 2017
Total Approved NMEs: 46 Small Molecules: 34 (74 %) Biologics: 12 (26 %) This is second best production rate of approvals since 1996 w...
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Michael Jackson’s Anti-Gravity Shoes: The Secret Behind the “Smooth Criminal” Lean
When Michael Jackson leaned forward at an impossible angle in his “ Smooth Criminal ” music video, fans around the world were left speechles...
