The US Food and Drug Administration (FDA) has approved Mylan Specialty's abbreviated new drug application for the generic equivalent to Sunovion's Xopenex inhalation solution, Levalbuterol inhalation solution USP, 0.31mg/3mL (0.0103%), ...
The US Food and Drug Administration (FDA) has approved Par Pharmaceutical Companies' abbreviated new drug application (ANDA) for fluvoxamine maleate 100mg and 150mg extended-release (ER) capsules. Fluvoxamine maleate ER capsules are ...
Tags: FDA, Drug, fluvoxamine maleate ER
India-based global pharmaceutical company Dr. Reddy's Laboratories has launched Zoledronic Acid injection (4 mg/5 mL), following the approval of its abbreviated new drug application (ANDA) from the Food and Drug Administration, in the US. ...
Tags: pharmaceutical company, pharmaceutical services, pharmaceutical
The USFDA has approved Teva Pharmaceutical Industries' abbreviated new drug application (ANDA) for generic Adderall XR capsules to treat attention deficit hyperactivity disorder. The ANDA is concerned with generic version of Shire's ...
Tags: FDA, Teva Pharmaceutical Industries, ANDA, Adderall XR capsules
The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) for Doxorubicin HCl Liposome Injection USP, 2 mg/ml. Doxorubicin HCl Liposome Injection USP, 2 mg/ml, which is ...
Tags: FDA, Sun Pharma, Pharmaceutical
The US Food and Drug Administration (FDA) has approved InnoPharma's abbreviated new drug application (ANDA) for acetylcysteine injection. The acetylcysteine injection, which is a generic equivalent of Cumberland Pharmaceuticals' Acetadote ...
Tags: FDA, acetylcysteine injection, Pharmaceuticals, acetaminophen
Famy Care has won final FDA approval for abbreviated new drug application (ANDA) of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.03mg, generic equivalent to Teva Branded Pharmaceutical Products' Nordette 28 tablets. Mylan ...
Tags: Medicine
The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' abbreviated new drug applications (ANDA) for the generic equivalents to Merck's Maxalt MLT tablets and Maxalt tablets. Rizatriptan Benzoate orally ...
Tags: US, FDA, Mylan Pharmaceuticals, ANDA, Maxalt MLT tablets, Maxalt tablets
US FDA has approved Watson Pharmaceuticals' abbreviated new drug application (ANDA) for Oxycodone and Acetaminophen tablets, USP 7.5 mg/500 mg and 10 mg/650 mg. The tablets are the generic equivalent to Endo Pharmaceuticals' Percocet ...
Tags: US FDA, ANDA, Watson Pharmaceuticals, Oxycodone and Acetaminophen tablets
Mylan's subsidiary Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phenytoin Chewable Tablets USP, 50 mg. Phenytoin is the generic ...
Tags: Mylan, Mylan Pharmaceuticals, US, FDA, ANDA, Phenytoin Chewable Tablets
The US FDA has approved Abbreviated New Drug Application (ANDA) for Breckenridge Pharmaceutical's rizatriptan benzoate tablets. Following the ANDA approval, the company has also annonunced the immediate launch of the tablets. ...
Tags: US FDA, ANDA, Breckenridge Pharmaceutical, rizatriptan benzoate tablets
The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application (ANDA) for calcium acetate capsules. The generic equivalent of Phoslo Gelcaps are used to treat hyperphosphatemia in patients with end stage ...
Tags: FDA, Perrigo ANDA, calcium acetate capsules
Depomed's lawsuits against Watson Laboratories and Par Pharmaceutical in relation to Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed. The company said that both the companies no longer sought ...
Tags: Depomed, Watson Laboratories, Par Pharmaceutical, lawsuit
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin. Mylan has commenced shipping the generic ...
Tags: FDA, Capsules Anda, Mylan Pharmaceutical, Medicine
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for generic Atacand HCT tablets to treat hypertension. Candesartan Cilexetil and Hydrochlorothiazide Tablets in 16/12.5mg, 32/12.5mg and 32/25mg ...
Tags: US FDA, hypertension medication, ANDA, hypertension