FDA Orange Book · active-ingredient family
Chloramphenicol sodium succinate
Chloramphenicol sodium succinate: 1 brand, 4 generics; first approved Aug 25, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- PARKEDALENDA 050155—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- ELKINS SINNANDA 0624061982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CHLORAMPHENICOL SODIUM SUCCINATEFRESENIUS KABI USAANDA 0623651982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - CHLORAMPHENICOL SODIUM SUCCINATEGRUPPO LEPETITANDA 062278—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ANGUSANDA 060132—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
44 yr 5 mo ago
All 5 applications were approved in 1982.
Brand (NDA) 120%
Generic (ANDA) 480%
Chloramphenicol sodium succinate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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