The U.S. Food and Drug Administration has issued an approval (status AP) for ANDA076877, an abbreviated new drug application submitted by Senores Pharms. The application covers two oral tablet products containing gabapentin at strengths of 600 mg and 800 mg.
Both products are currently marked as discontinued in the FDA database. The original submission (submission number 1) received approval on July 6, 2006, and a labeling supplement (submission number 4) was approved on September 24, 2014.
Cập nhật pháp chế24 thg 8, 2026•1 phút đọc
FDA Approves ANDA076877 for Gabapentin Tablets (Discontinued)
FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.
Tổng hợp bởi đội ngũ PharmaCountry · Nguồn: FDA.gov
Đánh giá
(0)
(0)
(0)
(0)
(0)
Bài viết khác
Xem tất cả bài viếtNghiên cứu & Báo cáo
Global Finished Dosage Manufacturing Landscape 2026
5 thg 10, 2026
Cập nhật pháp chếKorea Korus hit with 1‑month manufacturing suspension over missing post‑marketing safety test
28 thg 9, 2026
Phân tíchPharma distributors set delivery cut‑offs ahead of Chuseok holiday (Sep 21‑23)
28 thg 9, 2026
Để lại đánh giá