Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080044
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPOXYPHENE COMPOUND 65 ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE 389MG;32.4MG;65MG 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
12/22/1970 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/1983 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

09/16/1983 SUPPL-176 Manufacturing (CMC)

Label is not available on this site.

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