FDA Orange Book · active-ingredient family
Meclofenamate sodium
Meclofenamate sodium: 1 brand, 20 generics; first approved Sep 03, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
20
Listed patents
0
Presentations
24
Brand (NDA) products
Originator applications
- PARKE DAVISNDA 018006-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - EQ 100MG BASE CAPSULE ORAL Discontinued -
Generic (ANDA) products (20)
Abbreviated applications
- MECLOFENAMATE SODIUMBARRANDA 0728481989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMBARRANDA 0728091989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMCHARTWELL RXANDA 0722621988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMCHARTWELL RXANDA 0722631988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMVITARINEANDA 0717101988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMVITARINEANDA 0716841988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMUSL PHARMAANDA 0710071988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMUSL PHARMAANDA 0710081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMPAR PHARMANDA 0720771988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMPAR PHARMANDA 0720781988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMWATSON LABSANDA 0716401987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMWATSON LABSANDA 0716411987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - QUANTUM PHARMICSANDA 0713801987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - QUANTUM PHARMICSANDA 0713811987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMANI PHARMSANDA 07146919872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMAM THERAPANDA 0713621987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMAM THERAPANDA 0713631987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMWATSON LABSANDA 0704001986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMWATSON LABSANDA 0704011986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued - - MECLOFENAMATE SODIUMMYLANANDA 07108119862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx - EQ 50MG BASE CAPSULE ORAL Rx -
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
40 yr 9 mo ago
Most recent approval
38 yr 2 mo ago
Approvals span 1986–1989 across 21 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2095%
Meclofenamate 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.
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