The FDA’s ANDA 088269 concerns SLO‑BID, an oral extended‑release capsule that contains 50 mg of theophylline. The product’s marketing status is recorded as discontinued.
The agency has granted approval (status “AP”) for numerous submissions associated with this ANDA. Manufacturing (CMC) submissions—numbers 2, 4, 9, 11, 15, 16, 17, 26, 32, and 34—were approved between 1985‑03‑18 and 1998‑12‑01. Labeling submissions—numbers 21, 24, and 28—received approval on 1989‑06‑07, 1988‑10‑04, and 1990‑06‑21 respectively.
法规动态2026年9月15日•3 分钟阅读
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.
由 Pharmacountry 团队整理 · 来源： FDA.gov
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