Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200529
Company: CHARTWELL RX
Company: CHARTWELL RX
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 |
---|---|---|---|---|---|---|---|
11/30/2010 | 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 |
---|---|---|---|---|---|
05/12/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2021 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2016 | SUPPL-2 | 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 | 202711 | ZYDUS PHARMS |