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NEWS #PharmaBuzz
15 Oct 2021
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209708
19 Aug 2021
// PHARMABIZ
Drugs in Development
Details:
Sodium Acetate-generic Injection is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.
Lead Product(s): Sodium Acetate
Therapeutic Area: Nephrology Brand Name: Sodium Acetate-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Milla Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 09, 2024
Lead Product(s) : Sodium Acetate
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Recipient : Milla Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
A.forall Announces Launch of a Generic Version of Sodium Acetate Injection 4 mEq/mL
Details : Sodium Acetate-generic Injection is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake.
Product Name : Sodium Acetate-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 09, 2024
Details:
Woodward Pharma Services LLC, has acquired Lovaza (LO-VEY-ZA) soft gelatin capsules indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia from GlaxoSmithKline LLC (GSK).
Lead Product(s): Omega-3-Acid Ethyl Esters 90
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Lovaza
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: GSK
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 18, 2021
Lead Product(s) : Omega-3-Acid Ethyl Esters 90
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Recipient : GSK
Deal Size : Undisclosed
Deal Type : Acquisition
Woodward Pharma Services LLC Acquires LOVAZA(R) Capsules
Details : Woodward Pharma Services LLC, has acquired Lovaza (LO-VEY-ZA) soft gelatin capsules indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia from GlaxoSmithKline...
Product Name : Lovaza
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 18, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUCONAZOLE IN SODIUM CH...
Dosage Strength : 200MG/100ML (2MG/ML)
Approval Date : 2010-05-26
Application Number : 77909
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUCONAZOLE IN SODIUM CH...
Dosage Strength : 400MG/200ML (2MG/ML)
Approval Date : 2010-05-26
Application Number : 77909
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUCONAZOLE IN SODIUM CH...
Dosage Strength : 100MG/50ML (2MG/ML)
Approval Date : 2015-04-20
Application Number : 77909
RX/OTC/DISCN : RX
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUCONAZOLE IN DEXTROSE ...
Dosage Strength : 200MG/100ML (2MG/ML)
Approval Date : 2010-05-26
Application Number : 77988
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : FLUCONAZOLE IN DEXTROSE ...
Dosage Strength : 400MG/200ML (2MG/ML)
Approval Date : 2010-05-26
Application Number : 77988
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : MILRINONE LACTATE IN DEX...
Dosage Strength : EQ 20MG BASE/100ML (EQ 0...
Approval Date : 2005-07-20
Application Number : 77151
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : MILRINONE LACTATE IN DEX...
Dosage Strength : EQ 40MG BASE/200ML (EQ 0...
Approval Date : 2005-07-20
Application Number : 77151
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : MIVACURIUM CHLORIDE
Dosage Strength : EQ 10MG BASE/5ML (EQ 2MG...
Approval Date : 2021-10-12
Application Number : 209708
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : MIVACURIUM CHLORIDE
Dosage Strength : EQ 20MG BASE/10ML (EQ 2M...
Approval Date : 2021-10-12
Application Number : 209708
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : INJECTABLE; INJECTION
Proprietary Name : DECA-DURABOLIN
Dosage Strength : 50MG/ML
Approval Date : 1986-06-12
Application Number : 13132
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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