Assyro AI

FDA Orange Book · active-ingredient family

Chloramphenicol

Chloramphenicol is approved as 6 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CHLOROMYCETIN · NDA 050183

6

Brand (NDA)

10

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, for solution, injectable, ointment, solution/drops

ProductApplicantApplicationTEApproved
CHLOROMYCETINPARKE DAVISNDA 050183—Approved Prior to Jan 1, 1982
CHLOROMYCETINPARKEDALENDA 050143—Approved Prior to Jan 1, 1982
CHLOROMYCETINPARKE DAVISNDA 050153—Approved Prior to Jan 1, 1982
CHLOROMYCETINPARKEDALENDA 050156—Approved Prior to Jan 1, 1982
CHLOROPTICALLERGANNDA 050091—Approved Prior to Jan 1, 1982
CHLOROMYCETINPARKEDALENDA 050205—Approved Prior to Jan 1, 1982

Generic (ANDA) products (10)

ProductApplicantApplicationTEApproved
CHLORAMPHENICOLALCONANDA 062628—Sep 25, 1985
CHLOROFAIRPHARMAFAIRANDA 062439—Apr 21, 1983
CHLOROFAIRPHARMAFAIRANDA 062437—Apr 14, 1983
OPTOMYCINOPTOPICSANDA 062171—Mar 31, 1982
CHLORAMPHENICOLALTANAANDA 060133—Approved Prior to Jan 1, 1982
CHLOROPTIC S.O.P.ALLERGANANDA 061187—Approved Prior to Jan 1, 1982
ECONOCHLORALCONANDA 061648—Approved Prior to Jan 1, 1982
CHLORAMPHENICOLEPIC PHARMA LLCANDA 062042—Approved Prior to Jan 1, 1982
ECONOCHLORALCONANDA 061645—Approved Prior to Jan 1, 1982
OPHTHOCHLORPARKEDALEANDA 061220—Approved Prior to Jan 1, 1982

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.

Chloramphenicol — frequently asked questions

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

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