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BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AILEX PHARMS LLC · Approved 2018-11-30

Drug application

FDA Application #
ANDA202584
Application type
Abbreviated New Drug Application (Generic)
Brand name
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Generic name
Bismuth Subsalicylate
Active ingredients
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Dosage form
TABLET, CHEWABLE, TABLET, CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
AILEX PHARMS LLC
First approval
2018-11-30

Source

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Drugs@FDA application overview
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