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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207623
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREGABALIN PREGABALIN 20MG/ML SOLUTION;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
07/19/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PREGABALIN

SOLUTION;ORAL; 20MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYRICA PREGABALIN 20MG/ML SOLUTION;ORAL Prescription Yes AA 022488 UPJOHN
PREGABALIN PREGABALIN 20MG/ML SOLUTION;ORAL Prescription No AA 207623 ALKEM LABS LTD
PREGABALIN PREGABALIN 20MG/ML SOLUTION;ORAL Prescription No AA 212604 INVATECH
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