Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075588
Company: CONTRACT PHARMACAL

Products on ANDA 075588

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075588

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/2002/75588.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75588TA.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.

Labels for ANDA 075588

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