Cipla ANDA 077411 for Lamivudine and Zidovudine Tablet Approved by FDA

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.