← FDA Drug Approvals (Drugs@FDA)
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
- Authoritative
- Drugs@FDA application overview
- Machine
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