Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075588
Company: CONTRACT PHARMACAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Discontinued 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
04/08/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75588_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75588TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75588.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075588_ibuprofen-pseudoephedrine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2006 SUPPL-2 Labeling

Label is not available on this site.

10/09/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75588_Prntlbl.pdf

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