Northstar
FDA Approves ELINEST — Northstar Rx LLC
On March 28, 2012, Northstar Rx LLC won FDA approval of its ANDA for the combined oral contraceptive ELINEST (norgestrel and ethinyl estradiol), posit...
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Bionpharma
FDA Approves IBANDRONATE SODIUM — Bionpharma Inc.
# FDA Approves Generic Ibandronate Sodium from Bionpharma Inc. Bionpharma Inc. has received FDA approval for its generic ibandronate sodium oral form...
PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT
# FDA Approves ANDA for PHARMOBEDIENT PHARMOBEDIENT has received FDA approval for ANDA078995, marking the company's entry into an additional generic ...
Hope
FDA Approves SODIUM THIOSULFATE — Hope Pharmaceuticals
# FDA Approves Hope Pharmaceuticals' Sodium Thiosulfate Injection Hope Pharmaceuticals received FDA approval for sodium thiosulfate intravenous injec...
Merck
FDA Approves JANUMET XR — Merck Sharp & Dohme LLC
Merck Sharp & Dohme has received FDA approval for JANUMET XR, merging sitagliptin and metformin into an once-daily formulation expected to heighten ma...
Vertex
FDA Approves KALYDECO — Vertex Pharmaceuticals Incorporated
# FDA Approves Vertex Pharmaceuticals' KALYDECO for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for KALYDECO (ivacaftor...
GENUS
FDA Approves Unknown Drug — GENUS
GENUS Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA 200343), a development poised to bolster the manufacturer's...
Mayne
FDA Approves ISOTRETINOIN — Mayne Pharma
# FDA Approves Mayne Pharma's Generic Isotretinoin Mayne Pharma received FDA approval for its generic isotretinoin oral formulation (ANDA076485) on J...
Hikma
FDA Approves ARGATROBAN — Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous ARGATROBAN application in January 2012, broadening its product portfolio of a...
Alvogen,
FDA Approves OXYCODONE HYDROCHLORIDE — Alvogen, Inc.
Alvogen, Inc. announced FDA approval for its Abbreviated New Drug Application (ANDA202116) to manufacture generic oxycodone hydrochloride tablets, sig...
Sun
FDA Approves TRAMADOL HYDROCHLORIDE — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. received FDA approval to market the generic version of TRAMADOL HYDROCHLORIDE oral tablets, continuing the company...
Sun
FDA Approves TRAMADOL HYDROCHLORIDE — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has received FDA approval for its Abbreviated New Drug Application for the oral formulation of TRAMADOL HYDROCHLOR...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA
# FDA Approves ANDA for Strides Pharma Strides Pharma has received FDA approval for ANDA 202075, expanding its generic drug portfolio and positioning...
STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL
Strides Pharma International announced this week that its Abbreviated New Drug Application No. ANDA200812 had been approved by the FDA, paving the way...
Fresenius
FDA Approves MEROPENEM — Fresenius Kabi USA, LLC
# FDA Approves Fresenius Kabi's Generic Meropenem Injectable Fresenius Kabi USA, LLC received FDA approval for its generic meropenem intravenous form...
Unichem
FDA Approves LAMOTRIGINE — Unichem Pharmaceuticals (USA), Inc.
Unichem Pharmaceuticals (USA), Inc. announced the FDA approval of its oral LAMOTRIGINE generic formulation, a milestone that positions the company to ...
Sagent
FDA Approves CLINDAMYCIN — Sagent Pharmaceuticals
Sagent Pharmaceuticals has received FDA approval for the generic intramuscular injection of clindamycin phosphate, expanding its portfolio of branded ...
SpecGx
FDA Approves MORPHINE SULFATE — SpecGx LLC
# FDA Approves SpecGx LLC's Generic Morphine Sulfate Oral Formulation SpecGx LLC has received FDA approval for its generic morphine sulfate oral form...
Janssen
FDA Approves XARELTO — Janssen Pharmaceuticals, Inc.
# FDA Approves Janssen Pharmaceuticals' XARELTO (Rivaroxaban) Oral Anticoagulant Janssen Pharmaceuticals, Inc. received FDA approval for XARELTO (riv...
Rising
FDA Approves RAMIPRIL — Rising Pharma Holdings, Inc.
Rising Pharma Holdings, Inc. received FDA approval on June 8, 2011, for its ANDA091604 application to market the generic version of RAMIPRIL, an oral ...