API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
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).
Lead Product(s): Milrinone Lactate
Therapeutic Area: Cardiology/Vascular Diseases 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 April 22, 2021
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, of Sanofi-Aventis.
Lead Product(s): Milrinone Lactate
Therapeutic Area: Cardiology/Vascular Diseases 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 April 19, 2021