Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074911
Company: VALEANT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHRENILIN WITH CAFFEINE AND CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;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
08/22/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74911ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

02/28/2008 SUPPL-8 Labeling

Label is not available on this site.

11/30/2007 SUPPL-7 Labeling

Label is not available on this site.

03/05/2003 SUPPL-2 Labeling

Label is not available on this site.

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