FDA Orange Book · active-ingredient family
Estropipate
Estropipate is approved in 11 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESTROPIPATE×3 | DURAMED PHARMS BARR | ANDA 040296 | — | Nov 01, 1999 | |
| ESTROPIPATE×3 | PHARMOBEDIENT | ANDA 040359 | — | Aug 26, 1999 | |
| ESTROPIPATE×3 | BARR | ANDA 040135 | — | Nov 27, 1996 | |
| ESTROPIPATE | WATSON LABS | ANDA 081213 | — | Sep 23, 1993 | |
| ESTROPIPATE | WATSON LABS | ANDA 081214 | — | Sep 23, 1993 | |
| ESTROPIPATE | WATSON LABS | ANDA 081216 | — | Sep 23, 1993 | |
| ESTROPIPATE | WATSON LABS TEVA | ANDA 081215 | — | Sep 23, 1993 | |
| ORTHO-EST | SUN PHARM INDS INC | ANDA 089582 | — | Jul 17, 1991 | |
| ORTHO-EST | SUN PHARM INDS INC | ANDA 089567 | — | Feb 27, 1991 | |
| OGEN | PHARMACIA AND UPJOHN | ANDA 084710 | — | Approved Prior to Jan 1, 1982 | |
| OGEN .625RLD×4 | PFIZER | ANDA 083220 | — | 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.
Estropipate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
