FDA Orange Book · active-ingredient family
Colistimethate sodium
Colistimethate sodium: 1 brand, 6 generics; first approved Feb 26, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- COLY-MYCIN MRLDPH HEALTHNDA 050108—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- COLISTIMETHATE SODIUMRSXELLIA PHARMS APSANDA 2053562015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Rx AP - COLISTIMETHATE SODIUMSAGENT PHARMS INCANDA 2013652014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Rx AP - COLISTIMETHATE SODIUMAVET LIFESCIENCESANDA 2023592012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Rx AP - COLISTIMETHATE SODIUMFRESENIUS KABI USAANDA 0653642008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Rx AP - COLISTIMETHATE SODIUMNEXUSANDA 0651772004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL INJECTABLE INJECTION Discontinued — - COLISTIMETHATE SODIUMPHARMOBEDIENTANDA 0642161999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG 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
27 yr 11 mo ago
Most recent approval
11 yr 5 mo ago
Approvals span 1999–2015 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Colistimethate sodium: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
