Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Aripiprazole
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Laboratories Limited Receives Tentative USFDA Approval for ANDA of Aripiprazole Tablets
Details : 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.
Brand Name : Abilify-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 30, 2023
Lead Product(s) : Aripiprazole
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Quetiapine Hemifumarate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Gets ANDA Approval for Generic Quetiapine
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.
Brand Name : Seroquel XR
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 17, 2022
Lead Product(s) : Quetiapine Hemifumarate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Amitriptyline Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 Pharmac...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 20, 2021
Lead Product(s) : Amitriptyline Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Labs Gets USFDA Approval for Apremilast Tablets
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 m...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 19, 2021
Lead Product(s) : Apremilast
Therapeutic Area : Dermatology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Celecoxib
Therapeutic Area : Musculoskeletal
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 13, 2021
Lead Product(s) : Celecoxib
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Atenolol,Chlorthalidone
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Labs Receives ANDA Approval for Atenolol and Chlorthalidone Tablets
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.
Brand Name : Atenolol/Chlorthalidone-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 28, 2020
Lead Product(s) : Atenolol,Chlorthalidone
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Tolterodine Tartrate
Therapeutic Area : Urology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Labs Receives US FDA Approval to Market Generic Detrol Tablets
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 Pfize...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 06, 2020
Lead Product(s) : Tolterodine Tartrate
Therapeutic Area : Urology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Baclofen
Therapeutic Area : Musculoskeletal
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Unichem Lab Gets USFDA Nod for Baclofen Tablets; Stock Ends Higher
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 10, 2020
Lead Product(s) : Baclofen
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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