FDA Orange Book · active-ingredient family
Estrogens, conjugated; medroxyprogesterone acetate
Estrogens, conjugated; medroxyprogesterone acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PREMPHASE 14/14 · NDA 020527
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREMPHASE 14/14RLD×5 | WYETH PHARMS | NDA 020527 | — | Nov 17, 1995 | |
| PREMPHASE (PREMARIN;CYCRIN 14/14)×2 | WYETH PHARMS INC | NDA 020303 | — | Dec 30, 1994 |
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, conjugated; medroxyprogesterone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
