Home Applications 200691 Application 200691
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PHENYTOIN PHENYTOIN TABLET, CHEWABLE;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200691-001 PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200691-001 AB
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 2 · 41 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 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200691-001 PHENYTOIN 50MG TABLET, CHEWABLE / ORAL AB 2012-12-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phenytoin PHENYTOIN Rising Pharma Holdings, Inc. e95cad66-b5f9-4802-a35f-fed340bf09ab 2024-03-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200691 application number: ANDA200691
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-3850 Phenytoin Phenytoin Mylan Pharmaceuticals Inc. ANDA Current 0378-3850 Phenytoin Phenytoin Mylan Pharmaceuticals Inc. ANDA Current 0378-3850 Phenytoin Phenytoin Mylan Pharmaceuticals Inc. ANDA Current 0378-3850 Phenytoin Phenytoin Mylan Pharmaceuticals Inc. ANDA Current 0615-7764 Phenytoin Phenytoin NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 51079-129 Phenytoin Phenytoin Mylan Institutional Inc. ANDA Current