Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
Roche’s ENDEP (Amitriptyline HCl 150mg) ANDA085303 Approved; product now discontinued
The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.
Regulatorische Updates
19. Sept. 2026•1 Min. Lesezeit
Copley Pharm’s Amitriptyline Hydrochloride Tablet (ANDA 088423) Discontinued
The FDA lists Copley Pharm’s oral Amitriptyline Hydrochloride 50 mg tablet (product #001) under ANDA 088423 as discontinued.
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves Multiple Supplemental Submissions for Amitriptyline Hydrochloride Tablet (ANDA 085742)
The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA086148 for Amitriptyline Hydrochloride 150 mg Oral Tablet
The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
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.
Regulatorische Updates
25. Aug. 2026•1 Min. Lesezeit
FDA Lists ENDEP Amitriptyline Tablet Products (ANDA083639)
FDA’s ANDA083639 lists five ENDEP oral amitriptyline tablets (10‑100 mg) from Roche, all marked discontinued.
Regulatorische Updates
25. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA086746 for Amitriptyline Tablet – Lederle
FDA approved application ANDA086746 for an oral amitriptyline hydrochloride 25 mg tablet submitted by Lederle; the product is listed as discontinued.
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