Application 200502

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NARATRIPTANNARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo
002NARATRIPTANNARATRIPTAN HYDROCHLORIDETABLET;ORALEQ 2.5MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200502-001NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2011-02-28
A200502-002NARATRIPTANNARATRIPTAN HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALABRS2011-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200502-001AB
A200502-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALABRS2011-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200502-001NARATRIPTANEQ 1MG BASETABLET / ORALAB2011-02-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A200502-002NARATRIPTANEQ 2.5MG BASETABLET / ORALAB2011-02-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200502-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200502-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200502-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200502-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200502-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200502-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200502-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200502-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200502-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200502-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200502-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200502-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200502-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200502-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200502-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200502-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200502-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200502-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200502-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200502-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200502-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200502-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200502-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200502-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200502-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200502-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200502-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200502-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200502-002AB1782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
naratriptanNARATRIPTANHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.41c29652-32f8-48dc-9038-0e2195aa20842025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200502
application number: ANDA200502
ndc (product): 23155-055
ndc (product): 23155-054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-054naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-054naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-054naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-054naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-054NaratriptanNaratriptanHeritage Pharmaceuticals Inc.ANDACurrent
23155-054naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-055naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-055naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-055naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-055naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-055NaratriptanNaratriptanHeritage Pharmaceuticals Inc.ANDACurrent
23155-055naratriptannaratriptanHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent