Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)
FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Lists Watson Labs' Meclizine Hydrochloride 12.5 mg Tablet (ANDA 085195) as Discontinued
The FDA’s ANDA 085195 for Watson Labs’ oral Meclizine Hydrochloride 12.5 mg tablet is marked discontinued, indicating the product is no longer marketed.
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.
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
FDA Approves Supplemental ANDA 086178 for GLYCOPYRROLATE Tablet
FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.
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
FDA Discontinues GUANETHIDINE MONOSULFATE Oral Tablet (ANDA 086114)
Watson Labs' oral tablet GUANETHIDINE MONOSULFATE (product 001) is listed as discontinued in FDA records under ANDA 086114.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Lists ANDA083760 for Watson Labs' Pyridoxine Hydrochloride Injection (Discontinued)
The FDA database shows an ANDA (application ANDA083760) submitted by Watson Labs for a pyridoxine hydrochloride injectable (100 mg/mL) that is currently listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Labeling for Norethindrone/Ethinyl Estradiol Tablet (ANDA078379)
The FDA approved labeling submissions for the oral tablet containing norethindrone 0.4 mg and ethinyl estradiol 0.035 mg (ANDA078379) submitted by Watson Labs.
Regulatory Updates
Aug 29, 2026•1 min read
Watson Labs' Dexamethasone Sodium Phosphate Injection Discontinued (ANDA083702)
Watson Labs' injectable dexamethasone sodium phosphate (product 001) is listed as discontinued per FDA ANDA083702 filing.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA087274 for Hydroxyzine Injectable – Watson Labs
FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.
Regulatory Updates
Aug 25, 2026•1 min read
FDA ANDA 086095: Watson Labs Chlorpheniramine Injection Discontinued
The FDA lists ANDA 086095 for Watson Labs' chlorpheniramine maleate injectable (100 mg/mL). The product is marked discontinued.
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