Orange Book product · Brand (NDA)
CLOMID
CLOMIPHENE CITRATE
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
CLOMIPHENE CITRATE
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 016131
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.
- 1982SEROPHENEBrand (NDA)
NDA 018361 · EMD SERONO
- 2026CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 220673 · ASCENT PHARMS INC
- 2025CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 219781 · NOVITIUM PHARMA
- 2025CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 219406 · ACCORD HLTHCARE
- 2024CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 216545 · RUBICON RESEARCH
- 2024CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 216739 · APPCO
- 1999CLOMIPHENE CITRATEGeneric (ANDA)
ANDA 075528 · COSETTE
- 1988MILOPHENEGeneric (ANDA)
ANDA 072196 · GRANATA BIO CORP
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.
