Orange Book product · Generic (ANDA)
CLARITHROMYCIN
CLARITHROMYCIN
At a glance
Aug 30, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2007
19 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CLARITHROMYCIN
Strength
125MG/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 065382
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
- 2019CLARITHROMYCINGeneric (ANDA)
ANDA 206714 · JUBILANT CADISTA
- 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
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.

