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FDA Orange Book · active-ingredient family

Hydrocortisone acetate

Hydrocortisone acetate is approved as 7 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORTIFOAM · NDA 017351

7

Brand (NDA)

18

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered, cream, injectable, lotion, ointment, paste, powder

ProductApplicantApplicationTEApproved
CORTIFOAMRLDVIATRISNDA 017351—Feb 10, 1982
CORTEF ACETATERLD×2PHARMACIA AND UPJOHNNDA 008917—Approved Prior to Jan 1, 1982
CORTEF ACETATEPHARMACIA AND UPJOHNNDA 009378—Approved Prior to Jan 1, 1982
CORTRILPFIZERNDA 009164—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATE×2EPIC PHARMA LLCNDA 009637—Approved Prior to Jan 1, 1982
HYDROCORTONE×2MERCKNDA 008228—Approved Prior to Jan 1, 1982
HYDROCORTONEMERCKNDA 009018—Approved Prior to Jan 1, 1982

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
MICORT-HCLEGACY PHARMAANDA 040398—Mar 29, 2002
MICORT-HCLEGACY PHARMAANDA 040396—Feb 27, 2001
HYDROCORTISONE ACETATEIMPERIUMANDA 040259—Jul 29, 1999
HEMSOL-HCABLEANDA 081274—Jun 19, 1992
HYDROCORTISONE ACETATEPARKE DAVISANDA 089914—Jan 03, 1989
U-CORTSUN PHARMA CANADAANDA 089472—Jun 13, 1988
HYDROCORTISONE ACETATECENCIANDA 080419—Jan 25, 1982
CARMOL HCRLDFOUGERA PHARMSANDA 080505—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATEPUREPAC PHARMANDA 086050—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATERLDPUREPAC PHARMANDA 086052—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATE×2BEL MARANDA 083739—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATEWATSON LABSANDA 083128—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATE×2WATSON LABSANDA 083759—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATEWATSON LABSANDA 085214—Approved Prior to Jan 1, 1982
DRICORTINGRAM PHARMANDA 086207—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATEFERA PHARMSANDA 080828—Approved Prior to Jan 1, 1982
ORABASE HCACOLGATEANDA 083205—Approved Prior to Jan 1, 1982
HYDROCORTISONE ACETATEX GEN PHARMSANDA 085981—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.

Hydrocortisone acetate — 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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