← FDA DRUG APPROVALS
FDA ANDA · ANDA205770
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Sponsor: PH HEALTH
APPLICATION
ANDA205770
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-06
LATEST ACTION
2025-03-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEPrescription
BISMUTH SUBCITRATE POTASSIUM 140MG, METRONIDAZOLE 125MG, TETRACYCLINE HYDROCHLORIDE 125MG · CAPSULE · ORAL
Approval history
2025-03-06Labeling · Supplement 2 · standardAP
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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