Orange Book product · Brand (NDA)
PROGESTERONE
PROGESTERONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PROGESTERONE
Strength
50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 017362
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
- 1997CRINONEBrand (NDA)
NDA 020701 · ABBVIE
- —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.
