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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214475
Company: RISING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE;ORAL Prescription AB No Yes
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE;ORAL Prescription None No No
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE;ORAL Prescription 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
07/18/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214475Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2024 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
07/26/2024 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

FENOPROFEN CALCIUM

CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE;ORAL Prescription No AB 214475 RISING
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