Home Applications 215636 Application 215636
Type ANDA
Sponsor ZYDUS LIFESCIENCES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHYLENE BLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 10MG/2ML (5MG/ML) No No 002 METHYLENE BLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 50MG/10ML (5MG/ML) No No 003 METHYLENE BLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 5MG/ML (5MG/ML) No Yes 004 METHYLENE BLUE METHYLENE BLUE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215636-001 METHYLENE BLUE METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 A215636-002 METHYLENE BLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 A215636-003 METHYLENE BLUE METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 A215636-004 METHYLENE BLUE METHYLENE BLUE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2026-03-31
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.
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 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215636-003 METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-003 METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-004 METHYLENE BLUE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2026-03-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 77370 ORIG 2024-01-31