Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Restoril Capsules, 7.5mg, 15mg, 22.5mg and 40mg, of SpecGx LLC. Temazepam Capsules are indicated for short term treatment of insomnia.
Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg have an estimated market size of US$ 48 million for twelve months ending December 2017 according to IQVIA.
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