Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212623
Company: GRANULATION TECH
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
04/30/2021 ORIG-1 Approval STANDARD

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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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