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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091276
Company: GLENMARK 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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/02/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/02/2020 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/09/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

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 090403 CADILA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070673 SANDOZ

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 090403 CADILA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070674 SANDOZ
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