Home Applications 077526 Application 077526
Type ANDA
Sponsor CELLTRION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 5MG BASE No No 002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE TABLET;ORAL EQ 10MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077526-001 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 A077526-002 RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077526-001 RIZATRIPTAN BENZOATE EQ 5MG BASE TABLET / ORAL AB 2013-03-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077526-002 RIZATRIPTAN BENZOATE EQ 10MG BASE TABLET / ORAL AB 2013-03-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 3 · 41 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE DIRECT RX 673d584c-0691-d2fb-e053-2991aa0a7797 2026-03-17 Warnings, Adverse reactions Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Direct_Rx f754388d-77f1-0d8d-e053-6394a90a7b7e 2026-03-17 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE direct rx b3d981bc-3c9e-8a9e-e053-2995a90a8f65 2026-03-05 Warnings, Adverse reactions Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Bryant Ranch Prepack 11a7f243-3a8b-41fd-a9fa-1dd2dcafab93 2026-02-04 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE MAXALT RIZATRIPTAN BENZOATE Organon LLC 007b4644-e0e7-4863-9ae3-fe09676b3f5f 2026-01-29 Warnings, Adverse reactions Name fallback generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Bryant Ranch Prepack 6391d2a1-252e-4e50-9d80-4dce12eabc8f 2025-11-06 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE A-S Medication Solutions 187204ef-5370-476a-84b1-e3c54b60c6c2 2025-11-06 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Advanced Rx of Tennessee, LLC 4137a02e-dcec-c14c-e063-6294a90aa44f 2025-10-21 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE Creekwood Pharmaceuticals LLC b517896b-167e-47d5-801d-7458f80e8ee2 2025-10-09 Warnings, Adverse reactions Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Golden State Medical Supply, Inc. 07605de4-bef2-70e8-e063-6394a90a33cc 2025-08-20 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Aurobindo Pharma Limited a8e37688-426c-4290-933d-54a34ae86000 2025-08-06 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE REMEDYREPACK INC. 1e547fac-a9e5-4c7b-adba-4e6b75141183 2025-06-19 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE RIZAFILM RIZATRIPTAN BENZOATE Gensco Laboratories LLC fa32794e-d26d-e0bf-e053-6294a90abb0e 2025-04-27 Warnings, Adverse reactions Name fallback generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Proficient Rx LP e7414f2d-d7cf-41e5-b457-f5850e8bb7a7 2025-02-01 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Asclemed USA, Inc. 8fa794f4-4253-485d-b4ee-986178031339 2025-01-27 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Direct_Rx 05150193-cc2f-8b41-e063-6394a90a184c 2025-01-22 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE Direct Rx d60560d5-8e52-099d-e053-2a95a90a20af 2025-01-21 Warnings, Adverse reactions Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Bryant Ranch Prepack 2598cfb1-f875-43a5-aa10-246e026e9695 2024-12-10 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE RIZATRIPTAN BENZOATE Panacea Biotec Limited 9c70370d-72ac-e062-e25c-97d57e6397ab 2024-12-09 Warnings, Adverse reactions Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE Rizatriptan Benzoate RIZATRIPTAN BENZOATE Bryant Ranch Prepack 74971372-75c6-4682-adbf-1c8e7b748fc1 2024-10-01 Warnings, Adverse reactions Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69097-181 Rizatriptan benzoate Rizatriptan benzoate Cipla USA Inc. ANDA Current 69097-182 Rizatriptan benzoate Rizatriptan benzoate Cipla USA Inc. ANDA Current