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FDA Orange Book · active-ingredient family

Aspirin; caffeine; orphenadrine citrate

Aspirin; caffeine; orphenadrine citrate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NORGESIC · NDA 013416

1

Brand (NDA)

4

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
NORGESICRLD×2BAUSCHNDA 013416Oct 27, 1982

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE×2STEVENS JANDA 074988Apr 30, 1999
ORPHENGESIC×2GALT PHARMSANDA 075141May 29, 1998
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE×2SANDOZANDA 074654Dec 31, 1996
INVAGESIC×2CHARTWELL RXANDA 074817Nov 27, 1996

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Aspirin; caffeine; orphenadrine citrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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