Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074464
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;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
05/28/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74464ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74464.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/13/2006 SUPPL-5 Labeling

Label is not available on this site.

03/13/2006 SUPPL-4 Labeling

Label is not available on this site.

02/02/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-1 Manufacturing (CMC)

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 204243 AUROBINDO PHARMA LTD
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 202706 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202139 MYLAN
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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