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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210588
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription AB No No
ACETAZOLAMIDE ACETAZOLAMIDE 250MG 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
10/17/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAZOLAMIDE

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 211372 APPCO
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 207503 BRECKENRIDGE
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 211556 EYWA PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 205530 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 214282 MANKIND PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 210588 NOVITIUM PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 215101 RUBICON
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 209734 STRIDES PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 125MG TABLET;ORAL Prescription No AB 040195 TARO

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 211372 APPCO
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 207503 BRECKENRIDGE
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 084840 CHARTWELL MOLECULAR
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 211556 EYWA PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 205530 HERITAGE PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 214282 MANKIND PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 210588 NOVITIUM PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 215101 RUBICON
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 209734 STRIDES PHARMA
ACETAZOLAMIDE ACETAZOLAMIDE 250MG TABLET;ORAL Prescription No AB 040195 TARO
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