Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209487
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MELOXICAM | MELOXICAM | 5MG | CAPSULE;ORAL | Prescription | AB | No | No |
MELOXICAM | MELOXICAM | 10MG | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/01/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209487Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/27/2022 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
MELOXICAM
CAPSULE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MELOXICAM | MELOXICAM | 5MG | CAPSULE;ORAL | Prescription | No | AB | 209487 | LUPIN LTD |
MELOXICAM | MELOXICAM | 5MG | CAPSULE;ORAL | Prescription | No | AB | 211398 | NOVITIUM PHARMA |
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MELOXICAM | MELOXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 209487 | LUPIN LTD |
MELOXICAM | MELOXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211398 | NOVITIUM PHARMA |