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FDA Orange Book · active-ingredient family

Aspirin; caffeine; dihydrocodeine bitartrate

Aspirin; caffeine; dihydrocodeine bitartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SYNALGOS-DC · NDA 011483

1

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
SYNALGOS-DCRLDSUN PHARM INDUSTRIESNDA 011483Sep 06, 1983

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; dihydrocodeine bitartrate — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.