Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091240
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|---|---|
04/12/2011 | 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-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/26/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-1 | 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 | 018829 | CHARTWELL MOLECULES |
INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091276 | GLENMARK PHARMS LTD |
INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 091240 | HETERO LABS LTD III |
INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 070673 | SANDOZ |
INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 090403 | ZYDUS LIFESCIENCES |
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 | 018829 | CHARTWELL MOLECULES |
INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 070651 | CHARTWELL MOLECULES |
INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091276 | GLENMARK PHARMS LTD |
INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 091240 | HETERO LABS LTD III |
INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 070674 | SANDOZ |
INDOMETHACIN | INDOMETHACIN | 50MG | CAPSULE;ORAL | Prescription | No | AB | 090403 | ZYDUS LIFESCIENCES |