Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213226
Company: MSN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
04/13/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

PREGABALIN

TABLET, EXTENDED RELEASE;ORAL; 82.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA CR PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 209501 UPJOHN
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211687 ALVOGEN
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211593 ALVOGEN PINE BROOK
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213226 MSN
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211948 MYLAN
PREGABALIN PREGABALIN 82.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211889 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 165MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA CR PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 209501 UPJOHN
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211687 ALVOGEN
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211593 ALVOGEN PINE BROOK
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213313 APOTEX
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213226 MSN
PREGABALIN PREGABALIN 165MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211889 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 330MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA CR PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 209501 UPJOHN
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211687 ALVOGEN
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211593 ALVOGEN PINE BROOK
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213313 APOTEX
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213226 MSN
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211431 MYLAN
PREGABALIN PREGABALIN 330MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211889 SUN PHARM

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