Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants Approval for Prednisolone 5 mg Tablet (ANDA 080531) by Chartwell RX
The FDA approved application ANDA080531 for a 5 mg oral prednisolone tablet marketed by Chartwell RX, LLC, with multiple manufacturing and labeling supplements authorized.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 088622 for Amitriptyline Hydrochloride 50 mg Tablet (Watson Labs)
The FDA granted approval for ANDA 088622, an oral 50 mg Amitriptyline Hydrochloride tablet submitted by Watson Labs; the product is listed as discontinued.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Hydrochlorothiazide 50 mg Tablet (ANDA 088923)
The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Imipramine Hydrochloride (ANDA088292)
FDA grants approval for ANDA088292, an oral imipramine hydrochloride tablet by Strides Pharma Science Limited, with details on dosage, NDC codes, and submission history.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA081189 for Hydrochlorothiazide 25 mg Tablet by Watson Labs
The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
TABLICAPS Submits ANDA084632 for Discontinued Oral Aminophylline 100 mg Delayed‑Release Tablet
TABLICAPS has filed ANDA084632 for an oral aminophylline 100 mg delayed‑release tablet, currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA077533 for Terbinafine Oral Tablet
The FDA approved ANDA077533 for the oral terbinafine tablet (brand name Terbinafine). Sponsored by Invagen Pharms, the product is now listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves CILOSTAZOL Tablets (ANDA077831)
FDA has approved Chartwell Rx's ANDA077831 for oral CILOSTAZOL tablets in 50 mg and 100 mg strengths, with labeling updates approved in 2016.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Generic Carvedilol Tablets (ANDA 076373)
The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Nabumetone (ANDA078420) for Prescription Oral Tablets
The FDA has approved ANDA078420 for Nabumetone tablets (500 mg and 750 mg) marketed by ScieGen Pharmaceuticals, adding a new oral NSAID to the prescription market.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 086865 for Chlorpropamide Tablet (Discontinued)
The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Purepac Pharm Discontinues Methocarbamol Tablet Products (ANDA085718)
FDA records show Purepac Pharm has discontinued two oral methocarbamol tablet products (500 mg and 750 mg) under ANDA 085718.