Orange Book product · Brand (NDA)
PROMETRIUM
PROGESTERONE
At a glance
May 14, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 1998
28 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
PROGESTERONE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 019781
Product number
001
Marketing status
RX
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
- 1997CRINONEBrand (NDA)
NDA 020701 · ABBVIE
- —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.
