Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling and REMS Submissions for Discontinued OxyMorphone Hydrochloride ER Tablets (ANDA 079046)
The FDA records show OxyMorphone Hydrochloride extended‑release tablets are discontinued, yet several labeling and REMS submissions for the product have been approved.
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Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Multiple Clozapine Submissions; All Listed Tablet Products Discontinued
FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)
FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA210272 for Buprenorphine Transdermal Patch
The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Multiple Labeling and REMS Updates for Hydrocodone Bitartrate/Ibuprofen Oral Tablet (ANDA 076604)
The FDA has approved a series of labeling and REMS submissions for the prescription oral tablet combining 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen under ANDA 076604.