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Tag Archives: ANDA

Alembic Pharmaceuticals receives USFDA approval for Amantadine Hydrochloride Capsules

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules, USP, 100mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel Capsules, 100mg, of Endo Pharmaceuticals Inc. Amantadine Hydrochloride Capsules have ... Read More »

Aurobindo Pharma receives USFDA approval for Atomoxetine Capsules

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Atomoxetine capsules, 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg. Atomoxetine capsules are the AB rated generic equivalent of Eli Lilly and Company’s Strattera capsules. The product ... Read More »

Jubilant Life Sciences receives ANDA approval for Celecoxib Capsules

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, the generic version of Celebrex of GD Searle, which is used for the treatment of Osteoarthritis and Rheumatoid Arthritis. This is the first approval that the ... Read More »

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