FDA Orange Book · active-ingredient family
Clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride is approved in 9 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | APPCO | ANDA 207047 | AA | May 11, 2018 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | CHARTWELL RX | ANDA 206958 | AA | May 05, 2017 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | EXTROVIS | ANDA 203063 | — | May 25, 2016 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | AMNEAL PHARMS | ANDA 203513 | — | Mar 13, 2014 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 202409 | AA | Apr 30, 2013 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | RISING | ANDA 201821 | AA | Aug 28, 2012 | |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | PADAGIS US | ANDA 090902 | — | Jul 07, 2010 | |
| CLEOCIN | PFIZER | ANDA 062644 | AA | Apr 07, 1986 | |
| CLEOCIN | PHARMACIA AND UPJOHN | ANDA 061827 | — | Approved Prior to Jan 1, 1982 |
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.
Clindamycin palmitate hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
