Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203550
Company: DBL PHARMS
Company: DBL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | AA | No | No |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
02/08/2017 | 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 |
---|---|---|---|---|---|
11/05/2020 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/02/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
07/02/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
METHOCARBAMOL
TABLET;ORAL; 500MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 212623 | ALLIED |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 213967 | AUROBINDO PHARMA LTD |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 208507 | BEXIMCO PHARMS USA |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 203550 | DBL PHARMS |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 209312 | GRANULES |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 200958 | HANGZHOU BINJIANG |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 090200 | HETERO LABS LTD III |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 040489 | OXFORD PHARMS |
METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET;ORAL | Prescription | No | AA | 086988 | PRINSTON INC |
TABLET;ORAL; 750MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 212623 | ALLIED |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 213967 | AUROBINDO PHARMA LTD |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 208507 | BEXIMCO PHARMS USA |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 203550 | DBL PHARMS |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 209312 | GRANULES |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 200958 | HANGZHOU BINJIANG |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 090200 | HETERO LABS LTD III |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 040489 | OXFORD PHARMS |
METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET;ORAL | Prescription | No | AA | 086988 | PRINSTON INC |