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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209235
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG 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
12/01/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209235s000ltr.pdf

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

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 FREE ACID AND POTASSIUM SALT;30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE;ORAL Over-the-counter Yes 021374 GLAXOSMITHKLINE
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE;ORAL Over-the-counter No 209235 AUROBINDO PHARMA LTD
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