Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075141
Company: GALT PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORPHENGESIC ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 385MG;30MG;25MG TABLET;ORAL Discontinued None No No
ORPHENGESIC FORTE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770MG;60MG;50MG TABLET;ORAL Prescription AB 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
05/29/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75141ap.pdf

ORPHENGESIC

There are no Therapeutic Equivalents.

ORPHENGESIC FORTE

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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