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Regulatory UpdatesSep 10, 2026•1 min read

FDA Lists Discontinued Hydrocortisone Acetate Injection (ANDA085214)

By the PharmaCountry team

The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.

The U.S. Food and Drug Administration (FDA) has a record for an injectable product containing Hydrocortisone Acetate. The product, marketed by Watson Labs, is identified as a 50 mg/mL injectable solution. It is listed under application number ANDA085214. The FDA entry indicates the product is discontinued and was not designated as a reference drug or reference standard. No further marketing status or approval details are provided beyond the discontinuation notice.

Compiled by the PharmaCountry team · Source: FDA.gov

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