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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204853
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 75MG 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
05/08/2017 ORIG-1 Approval STANDARD

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-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091549 AMNEAL PHARMS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079175 AVANTHI INC
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200529 CHARTWELL RX
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203501 GLENMARK PHARMS LTD
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201807 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204853 NOVAST LABS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 074464 SANDOZ
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202711 ZYDUS PHARMS
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