Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074567
Company: OHM LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROHM COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;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
04/17/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/74567ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/074567.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2012 SUPPL-29 Labeling-Container/Carton Labels

Label is not available on this site.

01/09/2012 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

01/09/2012 SUPPL-27 Labeling

Label is not available on this site.

08/18/2008 SUPPL-26 Labeling

Label is not available on this site.

09/27/2006 SUPPL-23 Labeling

Label is not available on this site.

03/22/2006 SUPPL-20 Labeling

Label is not available on this site.

07/19/2004 SUPPL-17 Labeling

Label is not available on this site.

08/13/2002 SUPPL-9 Labeling

Label is not available on this site.

07/17/2002 SUPPL-8 Labeling

Label is not available on this site.

07/17/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

07/17/2002 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/17/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/2002 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/31/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2001 SUPPL-2 Labeling

Label is not available on this site.

01/28/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

IBUPROHM COLD AND SINUS

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

TABLET;ORAL; 200MG;30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Over-the-counter Yes 019771 PFIZER
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Over-the-counter No 077628 DR REDDYS LABS LTD
IBUPROHM COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Over-the-counter No 074567 OHM LABS
SINE-AID IB IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Over-the-counter No 019899 J AND J CONSUMER INC

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