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Results For "approvaL"

2474 News Found

Lupin receives approval from U.S. FDA for Varenicline Tablets
News | December 07, 2023

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.


Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval | December 07, 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa


Granules India received ANDA approval for Sildenafil for oral suspension
Drug Approval | December 06, 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million


Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States


Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
Drug Approval | December 01, 2023

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25


Lupin receives tentative approval from USFDA for Canagliflozin Tablets
Drug Approval | November 24, 2023

Lupin receives tentative approval from USFDA for Canagliflozin Tablets

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor


Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution
Drug Approval | November 24, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain


Strides receives USFDA approval for generic Suprep bowel prep kit
Drug Approval | November 23, 2023

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru