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Orange Book drug · Brand (NDA)

Symbravo

Meloxicam; Rizatriptan Benzoate

RLDNDA 215431 Axsome
Approved
Jan 30, 2025
Strengths
1
Listed patents
94

What does the FDA Orange Book show for Symbravo?

Symbravo contains Meloxicam; Rizatriptan Benzoate and is the new drug FDA Orange Book record for NDA 215431. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 215431

New drug application identity from the Orange Book snapshot.

Application holder
Axsome Therapeutics Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
94

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
1

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
00120MG;EQ 10MG BASETABLETORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Axsome Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 215431.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

94 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 10, 2045. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 215431 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Meloxicam; Rizatriptan Benzoate

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-215431

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 215431
RLDRS
Strength
20MG;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    1 yr 6 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    in 1 yr 6 mo

  4. Patent 10029010 expires

    Listed method-of-use patent (U-4133) expiration.

    in 9 yr 10 mo

  5. Patent 10058614 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  6. Patent 10137131 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  7. Patent 10195278 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  8. Patent 10265324 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  9. Patent 10265399 expires

    Listed method-of-use patent (U-4509) expiration.

    in 9 yr 10 mo

  10. Patent 10265400 expires

    Listed method-of-use patent (U-4509) expiration.

    in 9 yr 10 mo

  11. Patent 10307484 expires

    Listed method-of-use patent (U-4509) expiration.

    in 9 yr 10 mo

  12. Patent 10363312 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  13. Patent 10369224 expires

    Listed method-of-use patent (U-4134) expiration.

    in 9 yr 10 mo

  14. Patent 10369225 expires

    Listed method-of-use patent (U-4356) expiration.

    in 9 yr 10 mo

  15. Patent 10426839 expires

    Listed method-of-use patent (U-4135) expiration.

    in 9 yr 10 mo

  16. Patent 10456471 expires

    Listed method-of-use patent (U-4509) expiration.

    in 9 yr 10 mo

  17. Patent 10463736 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  18. Patent 10471014 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  19. Patent 10471069 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  20. Patent 10512692 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  21. Patent 10512693 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  22. Patent 10517950 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  23. Patent 10532101 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  24. Patent 10537642 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  25. Patent 10561664 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  26. Patent 10583144 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  27. Patent 10653777 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  28. Patent 10688102 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  29. Patent 10688185 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  30. Patent 10695429 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  31. Patent 10695430 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  32. Patent 10702535 expires

    Listed method-of-use patent (U-4136) expiration.

    in 9 yr 10 mo

  33. Patent 10702602 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  34. Patent 10722583 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  35. Patent 10729696 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  36. Patent 10729697 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  37. Patent 10729773 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  38. Patent 10758617 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  39. Patent 10758618 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  40. Patent 10780165 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  41. Patent 10780166 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  42. Patent 10799588 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  43. Patent 10821181 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  44. Patent 10821182 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  45. Patent 10894053 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  46. Patent 10905693 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  47. Patent 10918722 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  48. Patent 10933136 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  49. Patent 10933137 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  50. Patent 10940153 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  51. Patent 10987358 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  52. Patent 11013805 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  53. Patent 11013806 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  54. Patent 11020483 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  55. Patent 11045549 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  56. Patent 11135295 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  57. Patent 11207328 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  58. Patent 11219626 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  59. Patent 11266657 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  60. Patent 11285213 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  61. Patent 11331323 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  62. Patent 11369684 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  63. Patent 11426414 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  64. Patent 11433078 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  65. Patent 11433079 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  66. Patent 11471464 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  67. Patent 11471465 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  68. Patent 11504429 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  69. Patent 11510927 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  70. Patent 11571428 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  71. Patent 11602563 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  72. Patent 11607456 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  73. Patent 11617755 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  74. Patent 11617756 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  75. Patent 11617791 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  76. Patent 11628173 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  77. Patent 11712441 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  78. Patent 11738085 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  79. Patent 11759522 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  80. Patent 11801250 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  81. Patent 11806354 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  82. Patent 11826370 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  83. Patent 11865117 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  84. Patent 11944683 expires

    Listed method-of-use patent (U-1719) expiration.

    in 9 yr 10 mo

  85. Patent 12485176 expires

    Listed method-of-use patent (U-4133) expiration.

    in 9 yr 10 mo

  86. Patent 9821075 expires

    Listed drug product patent expiration.

    in 9 yr 10 mo

  87. Patent 12472256 expires

    Listed method-of-use patent (U-4356) expiration.

    in 12 yr

  88. Patent 12472257 expires

    Listed method-of-use patent (U-4134) expiration.

    in 12 yr

  89. Patent 12472258 expires

    Listed drug product patent expiration.

    in 12 yr

  90. Patent 12616752 expires

    Listed method-of-use patent (U-4510) expiration.

    in 12 yr

  91. Patent 12128052 expires

    Listed method-of-use patent (U-1719) expiration.

    in 14 yr 1 mo

  92. Patent 12551488 expires

    Listed method-of-use patent (U-1719) expiration.

    in 14 yr 1 mo

  93. Patent 12551489 expires

    Listed method-of-use patent (U-1719) expiration.

    in 14 yr 1 mo

  94. Patent 12370196 expires

    Listed method-of-use patent (U-1719) expiration.

    in 15 yr 8 mo

  95. Patent 12611413 expires

    Listed method-of-use patent (U-1719) expiration.

    in 15 yr 8 mo

  96. Patent 12005118 expires

    Listed method-of-use patent (U-1719) expiration.

    in 16 yr 9 mo

  97. Patent 12544383 expires

    Listed method-of-use patent (U-1719) expiration.

    in 18 yr 11 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040204220442046TodayExclusivity NP: 2028-01-30Exclusivity NPPatent 10029010: 2036-04-11Patent 10029010Patent 10058614: 2036-04-11Patent 10058614Patent 10137131: 2036-04-11Patent 10137131Patent 10195278: 2036-04-11Patent 10195278Patent 10265324: 2036-04-11Patent 10265324Patent 10265399: 2036-04-11Patent 10265399Patent 10265400: 2036-04-11Patent 10265400Patent 10307484: 2036-04-11Patent 10307484Patent 10363312: 2036-04-11Patent 10363312Patent 10369224: 2036-04-11Patent 10369224Patent 10369225: 2036-04-11Patent 10369225Patent 10426839: 2036-04-11Patent 10426839Patent 10456471: 2036-04-11Patent 10456471Patent 10463736: 2036-04-11Patent 10463736Patent 10471014: 2036-04-11Patent 10471014Patent 10471069: 2036-04-11Patent 10471069Patent 10512692: 2036-04-11Patent 10512692Patent 10512693: 2036-04-11Patent 10512693Patent 10517950: 2036-04-11Patent 10517950Patent 10532101: 2036-04-11Patent 10532101Patent 10537642: 2036-04-11Patent 10537642Patent 10561664: 2036-04-11Patent 10561664Patent 10583144: 2036-04-11Patent 10583144Patent 10653777: 2036-04-11Patent 10653777Patent 10688102: 2036-04-11Patent 10688102Patent 10688185: 2036-04-11Patent 10688185Patent 10695429: 2036-04-11Patent 10695429Patent 10695430: 2036-04-11Patent 10695430Patent 10702535: 2036-04-11Patent 10702535Patent 10702602: 2036-04-11Patent 10702602Patent 10722583: 2036-04-11Patent 10722583Patent 10729696: 2036-04-11Patent 10729696Patent 10729697: 2036-04-11Patent 10729697Patent 10729773: 2036-04-11Patent 10729773Patent 10758617: 2036-04-11Patent 10758617Patent 10758618: 2036-04-11Patent 10758618Patent 10780165: 2036-04-11Patent 10780165Patent 10780166: 2036-04-11Patent 10780166Patent 10799588: 2036-04-11Patent 10799588Patent 10821181: 2036-04-11Patent 10821181Patent 10821182: 2036-04-11Patent 10821182Patent 10894053: 2036-04-11Patent 10894053Patent 10905693: 2036-04-11Patent 10905693Patent 10918722: 2036-04-11Patent 10918722Patent 10933136: 2036-04-11Patent 10933136Patent 10933137: 2036-04-11Patent 10933137Patent 10940153: 2036-04-11Patent 10940153Patent 10987358: 2036-04-11Patent 10987358Patent 11013805: 2036-04-11Patent 11013805Patent 11013806: 2036-04-11Patent 11013806Patent 11020483: 2036-04-11Patent 11020483Patent 11045549: 2036-04-11Patent 11045549Patent 11135295: 2036-04-11Patent 11135295Patent 11207328: 2036-04-11Patent 11207328Patent 11219626: 2036-04-11Patent 11219626Patent 11266657: 2036-04-11Patent 11266657Patent 11285213: 2036-04-11Patent 11285213Patent 11331323: 2036-04-11Patent 11331323Patent 11369684: 2036-04-11Patent 11369684Patent 11426414: 2036-04-11Patent 11426414Patent 11433078: 2036-04-11Patent 11433078Patent 11433079: 2036-04-11Patent 11433079Patent 11471464: 2036-04-11Patent 11471464Patent 11471465: 2036-04-11Patent 11471465Patent 11504429: 2036-04-11Patent 11504429Patent 11510927: 2036-04-11Patent 11510927Patent 11571428: 2036-04-11Patent 11571428Patent 11602563: 2036-04-11Patent 11602563Patent 11607456: 2036-04-11Patent 11607456Patent 11617755: 2036-04-11Patent 11617755Patent 11617756: 2036-04-11Patent 11617756Patent 11617791: 2036-04-11Patent 11617791Patent 11628173: 2036-04-11Patent 11628173Patent 11712441: 2036-04-11Patent 11712441Patent 11738085: 2036-04-11Patent 11738085Patent 11759522: 2036-04-11Patent 11759522Patent 11801250: 2036-04-11Patent 11801250Patent 11806354: 2036-04-11Patent 11806354Patent 11826370: 2036-04-11Patent 11826370Patent 11865117: 2036-04-11Patent 11865117Patent 11944683: 2036-04-11Patent 11944683Patent 12485176: 2036-04-11Patent 12485176Patent 9821075: 2036-04-11Patent 9821075Patent 12472256: 2038-05-18Patent 12472256Patent 12472257: 2038-05-18Patent 12472257Patent 12472258: 2038-05-18Patent 12472258Patent 12616752: 2038-05-18Patent 12616752Patent 12128052: 2040-05-28Patent 12128052Patent 12551488: 2040-05-28Patent 12551488Patent 12551489: 2040-05-28Patent 12551489Patent 12370196: 2041-12-29Patent 12370196Patent 12611413: 2041-12-29Patent 12611413Patent 12005118: 2043-01-25Patent 12005118Patent 12544383: 2045-03-10Patent 12544383
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MELOXICAM; RIZATRIPTAN BENZOATE

Strength

20MG;EQ 10MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 215431

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NPNew product exclusivity (3 years)

    in 1 yr 6 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10029010in 9 yr 10 mo
U-4133
10058614in 9 yr 10 mo
Product
10137131in 9 yr 10 mo
ProductU-1719
10195278in 9 yr 10 mo
U-1719
10265324in 9 yr 10 mo
U-1719
10265399in 9 yr 10 mo
U-4509
10265400in 9 yr 10 mo
U-4509
10307484in 9 yr 10 mo
U-4509
10363312in 9 yr 10 mo
U-1719
10369224in 9 yr 10 mo
U-4134
10369225in 9 yr 10 mo
U-4356
10426839in 9 yr 10 mo
U-4135
10456471in 9 yr 10 mo
U-4509
10463736in 9 yr 10 mo
Product
10471014in 9 yr 10 mo
U-1719
10471069in 9 yr 10 mo
U-1719
10512692in 9 yr 10 mo
U-1719
10512693in 9 yr 10 mo
U-1719
10517950in 9 yr 10 mo
U-1719
10532101in 9 yr 10 mo
U-1719
10537642in 9 yr 10 mo
U-1719
10561664in 9 yr 10 mo
U-1719
10583144in 9 yr 10 mo
U-1719
10653777in 9 yr 10 mo
U-1719
10688102in 9 yr 10 mo
U-1719
10688185in 9 yr 10 mo
U-1719
10695429in 9 yr 10 mo
U-1719
10695430in 9 yr 10 mo
U-1719
10702535in 9 yr 10 mo
U-4136
10702602in 9 yr 10 mo
U-1719
10722583in 9 yr 10 mo
U-1719
10729696in 9 yr 10 mo
U-1719
10729697in 9 yr 10 mo
U-1719
10729773in 9 yr 10 mo
U-1719
10758617in 9 yr 10 mo
U-1719
10758618in 9 yr 10 mo
U-1719
10780165in 9 yr 10 mo
U-1719
10780166in 9 yr 10 mo
U-1719
10799588in 9 yr 10 mo
U-1719
10821181in 9 yr 10 mo
U-1719
10821182in 9 yr 10 mo
U-1719
10894053in 9 yr 10 mo
U-1719
10905693in 9 yr 10 mo
U-1719
10918722in 9 yr 10 mo
U-1719
10933136in 9 yr 10 mo
U-1719
10933137in 9 yr 10 mo
U-1719
10940153in 9 yr 10 mo
U-1719
10987358in 9 yr 10 mo
U-1719
11013805in 9 yr 10 mo
U-1719
11013806in 9 yr 10 mo
U-1719
11020483in 9 yr 10 mo
U-1719
11045549in 9 yr 10 mo
U-1719
11135295in 9 yr 10 mo
U-1719
11207328in 9 yr 10 mo
U-1719
11219626in 9 yr 10 mo
U-1719
11266657in 9 yr 10 mo
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U-1719
11331323in 9 yr 10 mo
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11471465in 9 yr 10 mo
U-1719
11504429in 9 yr 10 mo
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11510927in 9 yr 10 mo
U-1719
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U-1719
11602563in 9 yr 10 mo
U-1719
11607456in 9 yr 10 mo
U-1719
11617755in 9 yr 10 mo
U-1719
11617756in 9 yr 10 mo
U-1719
11617791in 9 yr 10 mo
U-1719
11628173in 9 yr 10 mo
U-1719
11712441in 9 yr 10 mo
U-1719
11738085in 9 yr 10 mo
U-1719
11759522in 9 yr 10 mo
U-1719
11801250in 9 yr 10 mo
U-1719
11806354in 9 yr 10 mo
U-1719
11826370in 9 yr 10 mo
U-1719
11865117in 9 yr 10 mo
U-1719
11944683in 9 yr 10 mo
U-1719
12485176in 9 yr 10 mo
U-4133
9821075in 9 yr 10 mo
ProductU-1719
12472256in 12 yr
U-4356
12472257in 12 yr
U-4134
12472258in 12 yr
Product
12616752in 12 yr
U-4510
12128052in 14 yr 1 mo
U-1719
12551488in 14 yr 1 mo
U-1719
12551489in 14 yr 1 mo
U-1719
12370196in 15 yr 8 mo
U-1719
12611413in 15 yr 8 mo
U-1719
12005118in 16 yr 9 mo
U-1719
12544383in 18 yr 11 mo
U-1719

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Meloxicam; Rizatriptan Benzoate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Symbravo: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 215431 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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