Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205215
Company: JUBILANT GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription AB No No
INDOMETHACIN INDOMETHACIN 50MG 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
08/25/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

INDOMETHACIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070719 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 018858 MYLAN
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070673 SANDOZ
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091401 SUN PHARM INDS INC
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 090403 ZYDUS PHARMS USA INC

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070756 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070624 MYLAN
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070674 SANDOZ
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091401 SUN PHARM INDS INC
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 090403 ZYDUS PHARMS USA INC

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