Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079065
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 375MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/04/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/11/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

METRONIDAZOLE

CAPSULE;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL METRONIDAZOLE 375MG CAPSULE;ORAL Prescription Yes AB 020334 PFIZER
METRONIDAZOLE METRONIDAZOLE 375MG CAPSULE;ORAL Prescription No AB 079065 ALEMBIC PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 375MG CAPSULE;ORAL Prescription No AB 076522 PAR PHARM

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