Orange Book product · Brand (NDA)
CRINONE
PROGESTERONE
At a glance
Jul 31, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 1997
29 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PROGESTERONE
Strength
8%
Dosage form
GEL
Route
VAGINAL
TE code
Not listed
Application
NDA 020701
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020MILPROSABrand (NDA)
NDA 201110 · FERRING PHARMS INC
- 2007ENDOMETRINBrand (NDA)
NDA 022057 · FERRING
- 1998PROMETRIUMBrand (NDA)
NDA 019781 · ACERTIS PHARMS
- —PROGESTERONEBrand (NDA)
NDA 017362 · ACTAVIS LABS UT INC
- —PROGESTERONEBrand (NDA)
NDA 009238 · LILLY
- —PROGESTASERTBrand (NDA)
NDA 017553 · ALZA
- 2026PROGESTERONEGeneric (ANDA)
ANDA 216363 · GLENMARK PHARMS
- 2025PROGESTERONEGeneric (ANDA)
ANDA 218391 · XIROMED
- 2023PROGESTERONEGeneric (ANDA)
ANDA 217707 · ACCORD HLTHCARE
- 2022PROGESTERONEGeneric (ANDA)
ANDA 215634 · XIROMED
- 2018PROGESTERONEGeneric (ANDA)
ANDA 210965 · EUGIA PHARMA
- 2018PROGESTERONEGeneric (ANDA)
ANDA 211285 · EUGIA PHARMA
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.
