Cipla has filed an Abbreviated New Drug Application (ANDA) identified as ANDA077221 for lamivudine oral tablets. The application covers two tablet products, both prescription‑only, with strengths of 150 mg (product number 001) and 300 mg (product number 002).
Both products are intended for oral administration and are not designated as reference drugs or reference standards. The active ingredient in each tablet is lamivudine, matching the listed strengths.
The submission record shows an original filing (submission type ORIG, number 1) that received approval on March 3, 2017. Subsequent labeling supplements (submission type SUPPL, numbers 1, 2, and 3) were each approved on September 30, 2019, all under standard review priority.
Cipla is listed as the sponsor for this ANDA, indicating its responsibility for the development and marketing of the lamivudine tablets pending final FDA approval.
法规动态2026年9月17日•3 分钟阅读
Cipla Submits ANDA077221 for Lamivudine Tablets (150 mg & 300 mg)
Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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