Orange Book product · Brand (NDA)
DELALUTIN
HYDROXYPROGESTERONE CAPROATE
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
HYDROXYPROGESTERONE CAPROATE
Strength
125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 016911
Product number
001
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.
- —HYDROXYPROGESTERONE CAPROATEBrand (NDA)
NDA 017439 · ALLERGAN
- —HYDROXYPROGESTERONE CAPROATEBrand (NDA)
NDA 018004 · EPIC PHARMA LLC
- —DELALUTINBrand (NDA)
NDA 010347 · BRISTOL MYERS SQUIBB
- 2019HYDROXYPROGESTERONE CAPROATEGeneric (ANDA)
ANDA 211142 · EUGIA PHARMA
- 2015HYDROXYPROGESTERONE CAPROATEGeneric (ANDA)
ANDA 200271 · ASPEN GLOBAL INC
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.
