Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019833
Company: WYETH CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Discontinued 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
09/19/1989 ORIG-1 Approval Type 3 - New Dosage Form 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
05/08/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1998 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-833S011.pdf
10/24/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/21/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/27/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1994 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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