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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215585
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;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
10/08/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

DICLOFENAC POTASSIUM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CATAFLAM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 076561 AMICI
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 215585 NOVAST LABS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075463 RK PHARMA
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075229 RUBICON
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 075219 TEVA
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET;ORAL Prescription No AB 215750 UMEDICA LABS PVT LTD
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