Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208363
Company: PURACAP PHARM LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter None 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
03/15/2018 ORIG-1 Approval STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208363Orig1s000ApprovRoutingSummary.pdf

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; EQ 200MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter Yes 021920 BIONPHARMA INC
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter No 202807 CATALENT
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter No 208363 PURACAP PHARM LLC

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