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Results For "reference-listed-drug"

176 News Found

Glenmark Pharmaceuticals USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet
News | April 17, 2025

Glenmark Pharmaceuticals USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablet

According to IQVIATM sales data for the 12-month period ending February 2025, the Adderall Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market3 achieved annual sales of approximately $421.7 million.


Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg
Drug Approval | April 17, 2025

Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA


Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Drug Approval | April 14, 2025

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial
Drug Approval | April 03, 2025

Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA


Glenmark Pharmaceuticals USA launches Vancomycin Hydrochloride for Injection
News | April 02, 2025

Glenmark Pharmaceuticals USA launches Vancomycin Hydrochloride for Injection

According to IQVIA sales data for the 12-month period ending January 2025, the Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial) market achieved annual sales of approximately $39.3 mn


Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


Glenmark Pharmaceuticals USA launches Epinephrine Injection USP
News | February 27, 2025

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP

This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.


Glenmark Pharmaceuticals USA launches Clindamycin Phosphate Foam, 1%
News | February 14, 2025

Glenmark Pharmaceuticals USA launches Clindamycin Phosphate Foam, 1%

Glenmark’s Clindamycin Phosphate Foam, 1% is bioequivalent and therapeutically equivalent to Evoclin Foam, 1%, of Mylan Pharmaceuticals.


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru