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Glenmark
FDA Approves ROSUVASTATIN CALCIUM — Glenmark Pharmaceutials Inc., USA

Glenmark Pharmaceuticals Inc. USA has received FDA approval for the oral route rosuvastatin calcium ANDA, entering the generic market for the highly p...

SUN
FDA Approves Unknown Drug — SUN PHARM

SUN PHARMaceuticals has received approval for the new drug application #ANDA079169, a development that is poised to expand the company’s footprint in ...

Trigen
FDA Approves HYDROMORPHONE HYDROCHLORIDE — Trigen Laboratories, LLC

Trigen Laboratories, LLC announced the FDA approval of its ANDA for oral hydromorphone hydrochloride tablets, adding a new generic entrant to the stro...

STRIDES
FDA Approves Unknown Drug — STRIDES PHARMA INTL

Stride Pharma International announced approval of its Abbreviated New Drug Application (ANDA) on July 5, 2016, indicating regulatory clearance to ente...

Mylan
FDA Approves FENOFIBRATE — Mylan Pharmaceuticals Inc.

On June 23, Mylan Pharmaceuticals Inc. was granted FDA approval for the Abbreviated New Drug Application #ANDA204475 for tablet and capsule forms of F...

Ingenus
FDA Approves PRIMAQUINE PHOSPHATE — Ingenus Pharmaceuticals, LLC

Ingenus Pharmaceuticals announced today that it received FDA approval for the ANDA206043, granting market exclusivity to its generic version of Primaq...

Strides
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Strides Pharma Science Limited

Strides Pharma Science Limited announced the FDA approval of its generic Hydrocodone Bitartrate and Acetaminophen products, a move anticipated to invi...

Hisun
FDA Approves IRBESARTAN — Hisun Pharmaceuticals USA Inc.

# FDA Approves Generic Irbesartan from Hisun Pharmaceuticals USA Inc. The FDA has approved Hisun Pharmaceuticals USA Inc.'s generic formulation of ir...

Aurolife
FDA Approves HYDROCODONE BITARTRATE AND IBUPROFEN — Aurolife Pharma, LLC

# FDA Approves Generic Hydrocodone Bitartrate and Ibuprofen Combination Aurolife Pharma, LLC has received FDA approval for a generic version of the h...

ACTAVIS
FDA Approves Unknown Drug — ACTAVIS LABS FL INC

Actavis Labs Florida, Inc. secured FDA approval for its generic sildenafil citrate tablets (20 mg), clearing the way for a competitive launch in the P...

Cipla
FDA Approves ATORVASTATIN CALCIUM — Cipla USA Inc.,

The FDA has approved a supplementary ANDA for oral atorvastatin calcium by Cipla USA Inc., allowing the company to expand its generic cholesterol-lowe...

Genentech,
FDA Approves TECENTRIQ — Genentech, Inc.

# FDA Approves Genentech's TECENTRIQ (atezolizumab) for Bladder Cancer Genentech, Inc. received FDA approval for TECENTRIQ (atezolizumab), a PD-L1 in...

PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT

Pharmobedient Continues Regulatory Expansion Pharmobedient has expanded its product portfolio with this latest FDA approval, positioning itself for br...

Aurolife
FDA Approves OXYMORPHONE HYDROCHLORIDE — Aurolife Pharma, LLC

Aurolife Pharma, LLC announced the FDA approval of its OxyMORPHONE HYDROCHLORIDE tablets, increasing generic availability in the opioid market and fac...

Collegium
FDA Approves XTAMPZA ER — Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical, Inc. capitalized on the FDA's April 26, 2016 approval of its XTAMPZA ER extended-release opioid, positioning itself for sign...

AMNEAL
FDA Approves Unknown Drug — AMNEAL PHARMS

# FDA Approves Amneal Pharmaceuticals Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA205081 on April 22, 2016, expandi...

Sandoz
FDA Approves MEROPENEM — Sandoz Inc

# FDA Approves Sandoz's Generic Meropenem for Intravenous Use Sandoz Inc. has received FDA approval for its generic meropenem injection, expanding th...

Amneal
FDA Approves MORPHINE SULFATE — Amneal Pharmaceuticals of New York LLC

# FDA Approves Amneal Pharmaceuticals' Generic Morphine Sulfate Oral Formulation Amneal Pharmaceuticals of New York LLC received FDA approval for its...

Rhodes
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Rhodes Pharmaceuticals LLC

Rhodes Pharmaceuticals received FDA approval for the ANDA for its generic version of Hydrocodone Bitartrate and Acetaminophen, a move that is expected...

AbbVie
FDA Approves VENCLEXTA — AbbVie Inc.

# FDA Approves AbbVie's VENCLEXTA (venetoclax) for Chronic Lymphocytic Leukemia AbbVie Inc. received FDA approval for VENCLEXTA (venetoclax), an oral...