Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070674
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
04/29/1987 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
04/15/2007 SUPPL-10 Labeling

Label is not available on this site.

07/01/1996 SUPPL-8 Labeling

Label is not available on this site.

04/29/1996 SUPPL-7 Labeling

Label is not available on this site.

02/01/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/23/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/10/1990 SUPPL-4 Labeling

Label is not available on this site.

10/24/1989 SUPPL-3 Labeling

Label is not available on this site.

02/02/1989 SUPPL-2 Labeling

Label is not available on this site.

03/03/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

INDOMETHACIN

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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