Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203166
Company: LGM PHARMA
Company: LGM PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | AB | No | No |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | AB | No | No |
NABUMETONE | NABUMETONE | 1GM | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
08/30/2019 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203166Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
NABUMETONE
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 090445 | ANNORA PHARMA |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 076009 | CHARTWELL MOLECULES |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 075280 | CHARTWELL RX |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 078671 | INVAGEN PHARMS |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 203166 | LGM PHARMA |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 078420 | SCIEGEN PHARMS INC |
NABUMETONE | NABUMETONE | 500MG | TABLET;ORAL | Prescription | No | AB | 091083 | WATSON LABS |
TABLET;ORAL; 750MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 090445 | ANNORA PHARMA |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 076009 | CHARTWELL MOLECULES |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 075280 | CHARTWELL RX |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 078671 | INVAGEN PHARMS |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 203166 | LGM PHARMA |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 078420 | SCIEGEN PHARMS INC |
NABUMETONE | NABUMETONE | 750MG | TABLET;ORAL | Prescription | No | AB | 091083 | WATSON LABS |