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Results For "Abbreviated-New-Drug-Application"

233 News Found

Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US


Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Drug Approval | November 04, 2022

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients


Alembic receives USFDA approval for Mesalamine ER Capsules
Drug Approval | November 03, 2022

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


Lupin receives approval from USFDA for Darunavir Tablets
Drug Approval | October 05, 2022

Lupin receives approval from USFDA for Darunavir Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Lupin receives US FDA approval for Mirabegron Extended-Release tablets
Drug Approval | September 30, 2022

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US


Aptar Pharma collaborates with Fluidda
News | September 25, 2022

Aptar Pharma collaborates with Fluidda

The companies will leverage their respective proprietary technology platforms


Lupin receives approval from US FDA for Diclofenac Sodium Topical Solution USP
Drug Approval | September 23, 2022

Lupin receives approval from US FDA for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US