Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018851
Company: HERITAGE PHARMS INC
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
05/18/1984 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
05/09/2016 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018851Orig1s025ltr.pdf
08/07/1992 SUPPL-23 Labeling

Label is not available on this site.

10/04/1989 SUPPL-22 Labeling

Label is not available on this site.

03/16/1989 SUPPL-21 Labeling

Label is not available on this site.

05/25/1990 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/13/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/23/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/13/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/19/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/14/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/24/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/24/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/24/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf
05/09/2016 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018851s025lbl.pdf

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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