Cipla has received FDA approval for ANDA 077411 for a fixed‑dose combination tablet containing lamivudine 150 mg and zidovudine 300 mg, listed as a prescription product.
The FDA submission record shows an original application (submission 1) with a letter dated 15 Sep 2006, followed by several labeling submissions (numbers 26, 27, 28). The latest labeling submission (28) was approved on 12 Dec 2019, confirming the product’s labeling status.
Regulatory UpdatesSep 13, 2026•3 min read
Cipla ANDA 077411 for Lamivudine and Zidovudine Tablet Approved by FDA
Cipla's ANDA 077411 for a prescription tablet combining lamivudine 150 mg and zidovudine 300 mg has been approved by the FDA.
Compiled by the Pharmacountry team · Source: FDA.gov
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