Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091549
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/01/2010 | 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 |
|---|---|---|---|---|---|
| 09/07/2023 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/02/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-2 | Labeling-Medication Guide, 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 |