Orange Book product · Brand (NDA)
CUPRIMINE
PENICILLAMINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PENICILLAMINE
Strength
250MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 019853
Product number
001
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.
- —DEPENBrand (NDA)
NDA 019854 · MYLAN SPECIALITY LP
- 2021PENICILLAMINEGeneric (ANDA)
ANDA 214363 · NAVINTA LLC
- 2021PENICILLAMINEGeneric (ANDA)
ANDA 215409 · BRECKENRIDGE
- 2021PENICILLAMINEGeneric (ANDA)
ANDA 213293 · INVAGEN PHARMS
- 2020PENICILLAMINEGeneric (ANDA)
ANDA 211735 · GRANULES
- 2020PENICILLAMINEGeneric (ANDA)
ANDA 212933 · LUPIN
- 2020PENICILLAMINEGeneric (ANDA)
ANDA 211867 · DR REDDYS
- 2020PENICILLAMINEGeneric (ANDA)
ANDA 213310 · APOTEX
- 2020PENICILLAMINEGeneric (ANDA)
ANDA 211497 · TEVA PHARMS USA
- 2019PENICILLAMINEGeneric (ANDA)
ANDA 211231 · PH HEALTH
- 2019PENICILLAMINEGeneric (ANDA)
ANDA 211196 · PH HEALTH
- 2019PENICILLAMINEGeneric (ANDA)
ANDA 210976 · WATSON LABS 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.
