← FDA DRUG APPROVALS

FDA ANDA · ANDA217511

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA217511
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-03
LATEST ACTION
2023-07-03
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

2023-07-03UNKNOWN · Original · standardAP
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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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