Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203434
Company: NOVAST LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;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
09/30/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203434Orig1s000ltr.pdf

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 090779 HERITAGE PHARMS INC
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204691 NOSTRUM LABS INC
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203434 NOVAST LABS LTD
ACETAZOLAMIDE ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 040904 ZYDUS PHARMS USA INC
DIAMOX ACETAZOLAMIDE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 012945 TEVA BRANDED PHARM

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