Orange Book product · Generic (ANDA)
CLARITHROMYCIN
CLARITHROMYCIN
At a glance
Apr 25, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CLARITHROMYCIN
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 206714
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLARITHROMYCIN
- 2000BIAXIN XLBrand (NDA)
NDA 050775 · ABBVIE
- 1993BIAXINBrand (NDA)
NDA 050698 · ABBVIE
- 1991BIAXINBrand (NDA)
NDA 050662 · ABBVIE
- 2022CLARITHROMYCINGeneric (ANDA)
ANDA 210459 · ALEMBIC
- 2018CLARITHROMYCINGeneric (ANDA)
ANDA 208987 · SUNSHINE
- 2016CLARITHROMYCINGeneric (ANDA)
ANDA 203243 · MPP PHARMA
- 2015CLARITHROMYCINGeneric (ANDA)
ANDA 203584 · HEC PHARM
- 2015CLARITHROMYCINGeneric (ANDA)
ANDA 202532 · LUPIN
- 2013CLARITHROMYCINGeneric (ANDA)
ANDA 202710 · NOVITIUM PHARMA
- 2012CLARITHROMYCINGeneric (ANDA)
ANDA 065489 · AUROBINDO
- 2007CLARITHROMYCINGeneric (ANDA)
ANDA 065283 · SANDOZ
- 2007CLARITHROMYCINGeneric (ANDA)
ANDA 065382 · SUN PHARM INDS LTD
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.

