Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019771
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;30MG TABLET;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/19/1989 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/23/2017 SUPPL-40 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019771Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019771Orig1s040ltr.pdf
09/02/2010 SUPPL-36 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019771s036ltr.pdf
05/19/2009 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019771s032ltr.pdf
06/20/2008 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019771s031ltr.pdf
02/23/2006 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s028ltr.pdf
04/17/2006 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019771s026ltr.pdf
10/17/2003 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19771slr022ltr.pdf
08/02/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/2001 SUPPL-20 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf
05/14/2001 SUPPL-18 Labeling

Label is not available on this site.

01/18/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1997 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/13/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1994 SUPPL-8 Labeling

Label is not available on this site.

09/04/1991 SUPPL-7 Labeling

Label is not available on this site.

06/15/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/28/1992 SUPPL-4 Labeling

Label is not available on this site.

10/17/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1994 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/23/2017 SUPPL-40 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019771Orig1s040lbl.pdf
05/23/2001 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19771S20lbl.pdf

ADVIL 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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