Assyro AI

FDA Orange Book · active-ingredient family

Estrogens, esterified

Estrogens, esterified is approved in 18 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

18

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
AMNESTROGEN×4BRISTOL MYERS SQUIBBANDA 083266—Approved Prior to Jan 1, 1982
ESTERIFIED ESTROGENSPVT FORMANDA 083414—Approved Prior to Jan 1, 1982
ESTERIFIED ESTROGENSPVT FORMANDA 083765—Approved Prior to Jan 1, 1982
ESTERIFIED ESTROGENSPVT FORMANDA 085907—Approved Prior to Jan 1, 1982
ESTERIFIED ESTROGENSSANDOZANDA 085302—Approved Prior to Jan 1, 1982
ESTRATABSOLVAYANDA 086715—Approved Prior to Jan 1, 1982
ESTRATABSOLVAYANDA 083209—Approved Prior to Jan 1, 1982
ESTRATABSOLVAYANDA 083856—Approved Prior to Jan 1, 1982
ESTRATABSOLVAYANDA 083857—Approved Prior to Jan 1, 1982
EVEXROCHE PALOANDA 084215—Approved Prior to Jan 1, 1982
EVEXROCHE PALOANDA 083376—Approved Prior to Jan 1, 1982
FEMOGENPVT FORMANDA 085076—Approved Prior to Jan 1, 1982
FEMOGENPVT FORMANDA 085008—Approved Prior to Jan 1, 1982
FEMOGENPVT FORMANDA 085007—Approved Prior to Jan 1, 1982
MENESTMONARCH PHARMSANDA 084951—Approved Prior to Jan 1, 1982
MENESTMONARCH PHARMSANDA 084948—Approved Prior to Jan 1, 1982
MENESTMONARCH PHARMSANDA 084950—Approved Prior to Jan 1, 1982
MENESTMONARCH PHARMSANDA 084949—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.

Estrogens, esterified — 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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