Home Applications 065044 Application 065044
Type ANDA
Sponsor MAYNE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 100MG No No 002 CYCLOSPORINE CYCLOSPORINE CAPSULE;ORAL 25MG 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 A065044-001 CYCLOSPORINE CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 A065044-002 CYCLOSPORINE CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20
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 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065044-001 CYCLOSPORINE 100MG CAPSULE / ORAL AB1 2000-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065044-002 CYCLOSPORINE 25MG CAPSULE / ORAL AB1 2000-12-20 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyclosporine CYCLOSPORINE Dr. Reddy's Laboratories Inc 64ec430a-e930-145c-e766-13fb49b64644 2024-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 065044 application number: ANDA065044
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51862-458 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-458 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-458 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-458 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-460 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-460 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-460 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current 51862-460 Cyclosporine Cyclosporine Mayne Pharma Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30634 ORIG 2000-12-20