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BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

ANDA

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | A205770 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: PYLERA(TE code: AB)

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OMICRON QUIMICA SAInactiveBISMUTH SUBCITRATE

DMF 127231997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 28, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 140MG;125MG;125MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 6, 2023

No patent or exclusivity listings for this strength.