Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040489
Company: OXFORD 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
01/29/2003 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
07/02/2020 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/05/2005 SUPPL-1 Labeling

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 200958 AUSTARPHARMA LLC
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 212623 GRANULATION TECH
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 209312 GRANULES
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 086989 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 200958 AUSTARPHARMA LLC
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 212623 GRANULATION TECH
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 209312 GRANULES
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

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