Home Applications 206775 Application 206775
Type ANDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) No No 002 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) No No 003 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) No No 004 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) No No 005 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 1GM/100ML (10MG/ML) No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206775-001 CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-002 CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-003 CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-004 CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 A206775-005 CARBOPLATIN CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 6 · 206 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 2026-08-18 06:07:40 2026-07 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2017-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206775-005 CARBOPLATIN 1GM/100ML (10MG/ML) INJECTABLE / INTRAVENOUS RS 2020-04-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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.
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 16729-295 Carboplatin Carboplatin Accord Healthcare, Inc. ANDA Current 16729-295 Carboplatin Carboplatin Accord Healthcare, Inc. ANDA Current 69448-005 PARAPLATIN Carboplatin Accord BioPharma Inc. ANDA Current 69448-005 PARAPLATIN Carboplatin Accord BioPharma Inc. ANDA Current 69448-005 PARAPLATIN Carboplatin Accord BioPharma Inc. ANDA Current 69448-005 PARAPLATIN Carboplatin Accord BioPharma Inc. ANDA Current