Home Applications 074641 Application 074641
Type ANDA
Sponsor CHARTWELL MOLECULES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE TABLET;ORAL 5MG 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 A074641-001 SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02
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 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074641-001 SELEGILINE HYDROCHLORIDE 5MG TABLET / ORAL 1996-08-02 cb3db0bc1861…
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 · 14 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Golden State Medical Supply, Inc. 040a97e5-efd1-4a2f-b737-2f13e5366d70 2025-11-24 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Marlex Pharmaceuticals, Inc. df88d6bf-0fda-3825-e053-2a95a90a3a75 2025-11-21 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Apotex Corp. 2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2 2025-09-22 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE Apotex Corp. 1924db3d-6a16-4496-cfd0-6903be146925 2025-09-22 Warnings, Adverse reactions Name fallback brand name: SELEGILINE HYDROCHLORIDE generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Bryant Ranch Prepack b8eb0a00-adc7-4aaf-987c-fa1b207b2996 2025-08-18 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Bryant Ranch Prepack 4848270a-1179-410c-b4e6-a7e555b3a988 2025-07-15 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE A2A Integrated Pharmaceuticals a59ff47b-4379-44f3-9d2c-f8c6121d1881 2025-02-28 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Rising Pharma Holdings, Inc. 23c4481f-d150-40c6-addb-b3e454ca914f 2024-08-07 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Chartwell RX, LLC 189ac32d-28b4-47c5-9de6-318e502eff3b 2024-05-08 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE i3 Pharmaceuticals, LLC c81e983b-455d-2e65-e053-2a95a90a3123 2024-03-20 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE A-S Medication Solutions f286c854-3b8c-44a8-b3b5-c828dbabb207 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Proficient Rx LP 57b564ef-c89b-4cf6-a11f-f67391d74e7e 2022-04-01 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE ZELAPAR SELEGILINE HYDROCHLORIDE Bausch Health US, LLC 380d7717-2a79-42f3-a712-efe5e7696ba0 2021-06-01 Warnings, Adverse reactions Name fallback generic name: SELEGILINE HYDROCHLORIDE Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE Novitium Pharma LLC e42d99b0-c62e-49d4-b792-1301bb539b92 2021-04-01 Warnings, Adverse reactions Name fallback brand name: Selegiline Hydrochloride generic name: SELEGILINE HYDROCHLORIDE