ANDA articles & resources on Made-in-China.com

US FDA Granted Final Approval for The Company's Abbreviated New Drug Application

Jan 23, 2014

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Bromfenac ...

Tags: Health, Medicine

Mylan Announced That Its U.S. Has Launched Mycophenolic Acid Delayed-Release Tablets

Jan 10, 2014

Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® ...

Tags: Mylan, Mycophenolic Acid Delayed-release Tablets

Actavis Plc Has Received Approval From The U.S. FDA on ANDA

Jan 10, 2014

Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a ...

Tags: Generic Version of Micardis, Actavis, Medicine News

Actavis PLC Would Prevent Actavis From Commercializing Its Anda Product Prior

Dec 30, 2013

Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and ...

Tags: Actavis, Warner Chilcott Company LLC, Abbreviated New Drug Application

Warner Chilcott Has Filed an ANDA with The U.S. FDA Seeking Approval

Dec 30, 2013

Today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal ...

Tags: Health, Medicine

Mylan Today Announced That Subsidiary Mylan Pharmaceuticals and Partner,Banner Pharmacaps

Dec 19, 2013

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. ...

Tags: Mylan, Targretin Suit, Treatment of Cutaneous Manifestations

Impax Has Started Shipment of Generic Solaraze

Nov 22, 2013

US-based specialty pharmaceutical firm Impax Laboratories (Impax) has started shipment of generic Solaraze (diclofenac sodium gel, 3%), a first-to-file product, through its generics division Global Pharmaceuticals. In order to ...

Tags: Health, Medicine

INSV Has Reported The US District Court Upheld All Four of The Patents Protecting AzaSite

Oct 10, 2013

InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against ...

Tags: Sandoz, Medicine

Par Pharmaceutical Has Received Final Approval From FDA for Its Anda for Clonidine HCl ER

Oct 10, 2013

US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) ...

Tags: Par Pharmaceutical, Medicine

Mylan Pharmaceuticals Has Introduced Voriconazole for Oral Suspension

Oct 8, 2013

Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...

Tags: Mylan, Antifungal Drug

AVNR Has Entered Into a Settlement Agreement with The US Unit

Sep 10, 2013

US-based Avanir Pharmaceuticals (AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking ...

Tags: Avanir Pharma, Medicine

Horizon Pharma and SkyePharma Have Filed a Patent Infringement Lawsuit

Aug 30, 2013

Horizon Pharma and SkyePharma have filed a patent infringement lawsuit against Watson Laboratories (WLF) and certain related companies like Actavis Pharma, Andrx and Actavis Inc. The lawsuit was filed in the US District Court for the ...

Tags: Horizon Pharma

Avanir Pharmaceuticals Has Settled Pending Patent Litigation

Aug 19, 2013

Avanir Pharmaceuticals has settled pending patent litigation concerning Sandoz's abbreviated new drug application (ANDA) to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. Under the ...

Tags: Avanir Pharmaceuticals

ANI Pharmaceuticals Has Signed a Binding Letter of Intent with Sofgen Pharmaceuticals

Aug 15, 2013

ANI Pharmaceuticals has signed a binding letter of intent with Sofgen Pharmaceuticals to develop and market an oral soft gel prescription product indicated for cardiovascular health. Development, manufacturing and regulatory activities of ...

Tags: ANI Pharmaceuticals, Prescription Product

Dr Reddy's Laboratories Introduced Donepezil Hydrochloride Tablets 23mg in The US

Jul 30, 2013

Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...

Tags: Drug Aricept, Generic Equivalent

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