Alembic Pharmaceuticals acquired final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, seventy five mg, one hundred mg, and a hundred and fifty mg. The permitted ANDA is therapeutically equivalent to the reference listed drug product (RLD), Norpramin Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and a hundred and fifty mg, of Validus Pharmaceuticals LLC.
Desipramine Hydrochloride Tablets, USP are indicated for the remedy of depression.
Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, seventy five mg, one hundred mg, and 150 mg have an envisioned market length of US$ 7 million for twelve months finishing
March 2021 in keeping with IQVIA.
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