Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090562
Company: MICRO LABS
Company: MICRO LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEFENAMIC ACID | MEFENAMIC ACID | 250MG | 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 |
---|---|---|---|---|---|---|---|
11/19/2010 | 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 |
---|---|---|---|---|---|
09/06/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/30/2019 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/30/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/30/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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01/21/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MEFENAMIC ACID
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091608 | BELCHER |
MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 091322 | LUPIN LTD |
MEFENAMIC ACID | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | No | AB | 090562 | MICRO LABS |
PONSTEL | MEFENAMIC ACID | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 015034 | AVION PHARMS |