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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086988
Company: PRINSTON INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription AA No No
METHOCARBAMOL METHOCARBAMOL 500MG 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
10/29/1979 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
11/08/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
11/08/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
11/08/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
06/09/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
06/19/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

METHOCARBAMOL

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 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 212623 MLV
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 040489 OXFORD PHARMS
METHOCARBAMOL METHOCARBAMOL 750MG TABLET;ORAL Prescription No AA 086988 PRINSTON INC

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 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 212623 MLV
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 040489 OXFORD PHARMS
METHOCARBAMOL METHOCARBAMOL 500MG TABLET;ORAL Prescription No AA 086988 PRINSTON INC
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