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FDA ANDA · ANDA202584

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Sponsor: AILEX PHARMS LLC

APPLICATION
ANDA202584
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-30
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE, TABLET, CAPSULE
MARKETING STATUS
Prescription

Products

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEPrescription
BISMUTH SUBSALICYLATE 262.4MG, N/A, N/A, METRONIDAZOLE N/A, 250MG, N/A, TETRACYCLINE HYDROCHLORIDE N/A, N/A, 500MG · TABLET, CHEWABLE, TABLET, CAPSULE · ORAL

Approval history

2025-03-31Labeling · Supplement 4 · standardAP
2024-07-08Labeling · Supplement 3 · standardAP
2021-12-15Labeling · Supplement 2 · standardAP
2021-03-05Labeling · Supplement 1 · standardAP
2018-11-30UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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