The U.S. Food and Drug Administration has issued an approval for ANDA083457 submitted by MK Labs. The original submission (submission number 1) was filed on May 2, 1973 and has an approved (AP) status.
The approved ANDA covers two oral capsule products marketed under the brand name VITAMIN A. Both products are recorded with a marketing status of Discontinued. Product 001 contains vitamin A palmitate equivalent to 50,000 units base, while product 002 contains vitamin A palmitate equivalent to 25,000 units base. Neither product is identified as a reference drug or reference standard.
Regulatory UpdatesSep 16, 2026•3 min read
FDA Approves ANDA083457 for MK Labs Vitamin A Capsules (Discontinued)
FDA approved ANDA083457 for MK Labs' oral Vitamin A capsule products, both listed as discontinued, with details on dosage strengths and submission date.
Compiled by the Pharmacountry team · Source: FDA.gov
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