Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074978
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription AB No 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
03/25/1998 ORIG-1 Approval Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74978ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/22/2019 SUPPL-48 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/09/2016 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/03/2010 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/074978Orig1s030ltr.pdf
07/31/2008 SUPPL-28 Labeling

Label is not available on this site.

10/29/2003 SUPPL-10 Labeling

Label is not available on this site.

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

Label is not available on this site.

01/29/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2000 SUPPL-4 Labeling

Label is not available on this site.

11/19/1999 SUPPL-3 Labeling

Label is not available on this site.

11/19/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/25/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/074978Orig1s000lbl.pdf

IBUPROFEN

SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 074978 ACTAVIS MID ATLANTIC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 205647 HI TECH
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 076925 L PERRIGO CO
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Prescription No AB 209204 TARO

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