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24 thg 9, 2026•1 phút đọc
DIPHENHYDRAMINE HYDROCHLORIDE
FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.
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13 thg 9, 2026•1 phút đọc
FDA Approves ANDA 084640 for DIPHEN Oral Elixir (USL Pharma)
FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.
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13 thg 9, 2026•1 phút đọc
FDA Lists Diphenhydramine Hydrochloride Injection (ANDA083533) as Discontinued
Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.
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11 thg 9, 2026•1 phút đọc
FDA Approves ANDA205336 for Diphenhydramine Hydrochloride Injectable
The FDA has approved application ANDA205336 for a prescription diphenhydramine hydrochloride injectable (50 mg/mL) product marketed by Avet Lifesciences for IM and IV use.
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9 thg 9, 2026•1 phút đọc
FDA Approves ANDA080800 for Diphenhydramine Hydrochloride Oral Capsule
FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.
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8 thg 9, 2026•1 phút đọc
FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs
FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.
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30 thg 8, 2026•1 phút đọc
FDA ANDA083061: Diphenhydramine Hydrochloride Capsules Discontinued
FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.