Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214799
Company: BAYSHORE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription AB No No
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription AB No No
METOLAZONE METOLAZONE 10MG 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
03/30/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

METOLAZONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription No AB 213251 ALEMBIC PHARMS LTD
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription No AB 214799 BAYSHORE PHARMS LLC
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription No AB 213827 INNOGENIX
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription No AB 076698 MYLAN
METOLAZONE METOLAZONE 2.5MG TABLET;ORAL Prescription No AB 076732 SANDOZ
ZAROXOLYN METOLAZONE 2.5MG TABLET;ORAL Prescription Yes AB 017386 LANNETT CO INC

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription No AB 213251 ALEMBIC PHARMS LTD
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription No AB 214799 BAYSHORE PHARMS LLC
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription No AB 213827 INNOGENIX
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription No AB 076698 MYLAN
METOLAZONE METOLAZONE 5MG TABLET;ORAL Prescription No AB 076466 SANDOZ
ZAROXOLYN METOLAZONE 5MG TABLET;ORAL Prescription Yes AB 017386 LANNETT CO INC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METOLAZONE METOLAZONE 10MG TABLET;ORAL Prescription No AB 213251 ALEMBIC PHARMS LTD
METOLAZONE METOLAZONE 10MG TABLET;ORAL Prescription No AB 214799 BAYSHORE PHARMS LLC
METOLAZONE METOLAZONE 10MG TABLET;ORAL Prescription No AB 213827 INNOGENIX
METOLAZONE METOLAZONE 10MG TABLET;ORAL Prescription No AB 076698 MYLAN
METOLAZONE METOLAZONE 10MG TABLET;ORAL Prescription No AB 076466 SANDOZ
ZAROXOLYN METOLAZONE 10MG TABLET;ORAL Prescription Yes AB 017386 LANNETT CO INC

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