Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074916
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;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
04/30/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74916ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-51 Labeling-Package Insert

Label is not available on this site.

03/03/2015 SUPPL-50 Labeling-Package Insert

Label is not available on this site.

12/16/2014 SUPPL-47 Labeling-Container/Carton Labels

Label is not available on this site.

11/26/2012 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

05/13/2010 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

11/28/2007 SUPPL-27 Labeling

Label is not available on this site.

11/28/2007 SUPPL-25 Labeling

Label is not available on this site.

11/28/2007 SUPPL-23 Labeling

Label is not available on this site.

11/28/2007 SUPPL-21 Labeling

Label is not available on this site.

10/25/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/2001 SUPPL-5 Labeling

Label is not available on this site.

04/25/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/29/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/29/2001 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/13/1999 SUPPL-1 Labeling

Label is not available on this site.

IBUPROFEN

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

SUSPENSION;ORAL; 100MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S ADVIL-FLAVORED IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S ELIXSURE IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 021604 MOBERG PHARMA NORTH
CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074937 PERRIGO
CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter Yes 020516 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074916 ACTAVIS MID ATLANTIC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210602 APTAPHARMA INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 200457 ARISE PHARMS
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209179 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209207 TARO

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