The U.S. Food and Drug Administration (FDA) has a record for an oral tablet product named Diphynoxylate Hydrochloride and Atropine Sulfate. The product, submitted by sponsor ASCOT, is identified by product number 001 and was filed under application number ANDA087934.
Key details of the product include:
- Route of administration: Oral
- Dosage form: Tablet
- Active ingredients: Diphenoxylate Hydrochloride 2.5 mg and Atropine Sulfate 0.025 mg per tablet
- Reference drug status: No
- Reference standard status: No
- Marketing status: Discontinued
No further information on the reason for discontinuation is provided in the FDA filing.
Regulatorische Updates15. Sept. 2026•3 Min. Lesezeit
FDA Discontinues Diphynoxylate Hydrochloride/Atropine Sulfate Tablet (ANDA 087934)
FDA records show ASCOT's oral tablet containing diphenoxylate hydrochloride 2.5 mg and atropine sulfate 0.025 mg is listed as discontinued under ANDA 087934.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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