Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019899
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SINE-AID IB 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
12/31/1992 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
05/15/2017 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019899Orig1s019ltr.pdf
02/27/2006 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019899s018ltr.pdf
07/29/2003 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19899slr015ltr.pdf
05/02/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
09/03/2002 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
11/29/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/06/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19899slr008,011,012ltr.pdf
06/14/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1993 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2017 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019899Orig1s019lbl.pdf
07/29/2003 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19899slr015_motrin_lbl.pdf

SINE-AID IB

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English