Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208681
Company: ORIT LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription AB No No
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;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
06/20/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

METRONIDAZOLE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL METRONIDAZOLE 250MG TABLET;ORAL Prescription Yes AB 012623 GD SEARLE LLC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 079067 ALEMBIC PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 203974 AUROBINDO PHARMA LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 206560 CADILA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 209794 CADILA PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 207309 FLAMINGO PHARMS
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 205245 HERITAGE PHARMS INC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070772 INNOGENIX
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 209096 LUPIN LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 208681 ORIT LABS LLC
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070040 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070027 TEVA PHARMS USA
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 203458 UNICHEM LABS LTD
METRONIDAZOLE METRONIDAZOLE 250MG TABLET;ORAL Prescription No AB 070035 WATSON LABS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLAGYL METRONIDAZOLE 500MG TABLET;ORAL Prescription Yes AB 012623 GD SEARLE LLC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 079067 ALEMBIC PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 203974 AUROBINDO PHARMA LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 206560 CADILA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 209794 CADILA PHARMS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 207309 FLAMINGO PHARMS
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 205245 HERITAGE PHARMS INC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070772 INNOGENIX
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 209096 LUPIN LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 208681 ORIT LABS LLC
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070033 PLIVA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070039 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 208162 STRIDES PHARMA
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 203458 UNICHEM LABS LTD
METRONIDAZOLE METRONIDAZOLE 500MG TABLET;ORAL Prescription No AB 070044 WATSON LABS INC

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