Orange Book product · Generic (ANDA)
PENICILLAMINE
PENICILLAMINE
At a glance
Aug 19, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PENICILLAMINE
Strength
250MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 213293
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PENICILLAMINE
- —CUPRIMINEBrand (NDA)
NDA 019853 · VALEANT PHARMS INTL
- —DEPENBrand (NDA)
NDA 019854 · MYLAN SPECIALITY LP
- 2021PENICILLAMINEGeneric (ANDA)
ANDA 214363 · NAVINTA LLC
- 2021PENICILLAMINEGeneric (ANDA)
ANDA 215409 · BRECKENRIDGE
- 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.
