Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090200
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|---|---|
11/06/2009 | ORIG-1 | Approval |
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 |