FDA Orange Book · active-ingredient family
Carboprost tromethamine
Carboprost tromethamine: 1 brand, 13 generics; first approved Jul 02, 2019; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
13
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- PFIZERNDA 017989—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (13)
Abbreviated applications
- CARBOPROST TROMETHAMINESOMERSET THERAPS LLCANDA 2195292026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEMICRO LABSANDA 2180132024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEANI PHARMSANDA 2159012024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Discontinued — - CARBOPROST TROMETHAMINEGLANDANDA 2176572023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEONESOURCE SPECIALTYANDA 2168972023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEALEMBICANDA 2171982023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEEUGIA PHARMAANDA 2169392023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINESOLA PHARMSANDA 2168242023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINECAPLINANDA 2168822023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINELONG GROVE PHARMSANDA 2144992022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEAMNEALANDA 2153372022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINESUNNYANDA 2131182021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP - CARBOPROST TROMETHAMINEDR REDDYSANDA 2119412019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/ML INJECTABLE INJECTION Rx AP
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
7 yr 4 mo ago
Most recent approval
4 mo ago
Approvals span 2019–2026 across 14 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1393%
Carboprost tromethamine: 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.
