FDA Orange Book · active-ingredient family
Meropenem
Meropenem: 3 brands, 13 generics; first approved Jun 21, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
13
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- MEROPENEMRLDRSHQ SPCLT PHARMANDA 2152122023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/VIAL POWDER INTRAVENOUS Rx AP - B BRAUN MEDICALNDA 20210620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx — 1GM/VIAL POWDER INTRAVENOUS Rx — - MERREM IVRLDPFIZERNDA 05070619962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL INJECTABLE INJECTION Discontinued — 500MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- MEROPENEMBROOKS STERISCIENCEANDA 2190842025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2GM/VIAL POWDER INTRAVENOUS Rx AP - MEROPENEMQILUANDA 21642420242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMBROOKS STERISCIENCEANDA 21615420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMHQ SPCLT PHARMAANDA 21077320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMEUGIA PHARMAANDA 20583520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMACS DOBFAR SPAANDA 20413920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMGLANDANDA 20614120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMSAVIOR LIFETEC CORPANDA 20608620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMAMNEAL PHARMSANDA 20588320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMDAEWOONG PHARM COANDA 20485420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — - MEROPENEMRSACS DOBFARANDA 09140420112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Rx AP 1GM/VIAL INJECTABLE INJECTION Rx AP - MEROPENEMSANDOZANDA 09120120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/VIAL INJECTABLE INJECTION Discontinued — - MEROPENEMHOSPIRA INCANDA 09094020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL INJECTABLE INJECTION Discontinued — 1GM/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
30 yr 9 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1996–2025 across 16 FDA applications.
Brand (NDA) 319%
Generic (ANDA) 1381%
Meropenem: 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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- 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.
