Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074654
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 385MG;30MG;25MG TABLET;ORAL Prescription None No No
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770MG;60MG;50MG TABLET;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
12/31/1996 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
09/13/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

09/14/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/08/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE

TABLET;ORAL; 770MG;60MG;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770MG;60MG;50MG TABLET;ORAL Prescription No AB 074654 SANDOZ
ORPHENGESIC FORTE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770MG;60MG;50MG TABLET;ORAL Prescription No AB 075141 GALT PHARMS

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