Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Labetalol Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Caplin Steriles Gets USFDA Nod for Labetalol Hydrochloride Injection
Details : U.S FDA has given Abbreviated New Drug Application labetalol hydrochloride injection USP, 100 mg/20 mL (5 mg/mL) and 200mg/40 mL (5 mg/mL) multiple-dose vials, a generic therapeutic equivalent version of Trandate injection, of Sebela Ireland Limited.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 09, 2021
Lead Product(s) : Labetalol Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Prochlorperazine Edisylate
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Caplin Steriles Receives USFDA Approval for Prochlorperazine Edisylate Injection
Details : Abbreviated New Drug Application (ANDA) is granted for Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) Vials presentations, a generic therapeutic equivalent version of (RLD), COMPAZINE Injection, of SmithKlineBeecham Corporation, USA.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 23, 2021
Lead Product(s) : Prochlorperazine Edisylate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Milrinone Lactate
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Caplin Steriles Gets US FDA Approval for Generic Bloxiverz Injection
Details : Caplin Steriles has been granted final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) neostigmine methylsulfate injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 22, 2021
Lead Product(s) : Milrinone Lactate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Milrinone Lactate
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Caplin Steriles Receives Final USFDA Approval for Milrinone Lactate Injection
Details : Caplin Steriles has been granted final approval from the USFDA for its ANDA Milrinone Lactate Injection USP, 10 mg/10 mL, 20 mg/20 mL, 50 mg/50 mL, Single-dose vial presentation, a generic therapeutic equivalent version of, PRIMACOR Injection, 1 mg/mL, o...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 19, 2021
Lead Product(s) : Milrinone Lactate
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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