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Aripiprazole action includes a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. It is approved by USFDA for the treatment of schizophrenia and bipolar I disorder in adults.
Lead Product(s): Aripiprazole
Therapeutic Area: Psychiatry/Psychology Product Name: Abilify-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2023
Details:
Quetiapine fumarate Extended-Release Tablets acts as dopamine type 2 (D2) and serotonin type 2A (5HT2A) antagonism, which is indicated for the treatment of Schizophrenia and Bipolar I disorder.
Lead Product(s): Quetiapine Hemifumarate
Therapeutic Area: Psychiatry/Psychology Product Name: Seroquel XR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
The ANDA approval is for Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the USFDA to market a generic version of ELAVIL (Amitriptyline Hydrochloride) 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg of AstraZeneca Pharmaceuticals LP.
Lead Product(s): Amitriptyline Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2021
Details:
Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Amgen’s Otezla® (apremilast) Tablets, 10 mg, 20 mg, and 30 mg.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 19, 2021
Details:
Unichem Laboratories announced that it has received ANDA approval for its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg from the USFDA to market a generic version of CELEBREX® (Celecoxib) Capsules of G.D. Searle LLC, Division of Pfizer Inc.
Lead Product(s): Celecoxib
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
Atenolol and Chlorthalidone Tablets are indicated for the treatment of hypertension, to lower blood pressure. It is generic version of Tenoretic (atenolol and chlorthalidone) tablets.
Lead Product(s): Atenolol,Chlorthalidone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Atenolol/Chlorthalidone-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2020
Details:
Unichem Laboratories has received ANDA approval for its DETROL® (tolterodine tartrate) Tablets, USP 1 mg and 2 mg from the United States Food and Drug Administration (USFDA) to market a generic version of DETROL® (tolterodine tartrate) tablets of Pfizer Inc.
Lead Product(s): Tolterodine Tartrate
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
Baclofen Tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Lead Product(s): Baclofen
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2020
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