Home Applications 209264 Application 209264
Type ANDA
Sponsor AILEX PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CROMOLYN SODIUM CROMOLYN SODIUM CONCENTRATE;ORAL 100MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209264-001 CROMOLYN SODIUM CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209264-001 AA
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 · 42 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 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63629-2483 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2483 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2483 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2485 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2485 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2485 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 63629-2485 CROMOLYN SODIUM CROMOLYN SODIUM Bryant Ranch Prepack ANDA Current 69784-200 CROMOLYN SODIUM CROMOLYN SODIUM Woodward Pharma Services LLC ANDA Current 69784-200 CROMOLYN SODIUM CROMOLYN SODIUM Woodward Pharma Services LLC ANDA Current 69784-200 CROMOLYN SODIUM CROMOLYN SODIUM Woodward Pharma Services LLC ANDA Current 69784-200 CROMOLYN SODIUM CROMOLYN SODIUM Woodward Pharma Services LLC ANDA Current 69784-200 CROMOLYN SODIUM CROMOLYN SODIUM Woodward Pharma Services LLC ANDA Current 70556-101 CROMOLYN SODIUM CROMOLYN SODIUM Ailex Pharmaceuticals, LLC ANDA Current 70556-101 CROMOLYN SODIUM CROMOLYN SODIUM Ailex Pharmaceuticals, LLC ANDA Current 70556-101 CROMOLYN SODIUM CROMOLYN SODIUM Ailex Pharmaceuticals, LLC ANDA Current 70556-102 Cromolyn Sodium Cromolyn Sodium Ailex Pharmaceuticals, LLC ANDA Current 70556-102 Cromolyn Sodium Cromolyn Sodium Ailex Pharmaceuticals, LLC ANDA Current 70556-102 Cromolyn Sodium Cromolyn Sodium Ailex Pharmaceuticals, LLC ANDA Current 76204-025 Cromolyn Sodium Oral Solution (Concentrate) Cromolyn Sodium Oral Solution (Concentrate) Ritedose Pharmaceuticals, LLC ANDA Current 76204-025 Cromolyn Sodium Oral Solution (Concentrate) Cromolyn Sodium Oral Solution (Concentrate) Ritedose Pharmaceuticals, LLC ANDA Current 76204-025 Cromolyn Sodium Oral Solution (Concentrate) Cromolyn Sodium Oral Solution (Concentrate) Ritedose Pharmaceuticals, LLC ANDA Current 76204-025 Cromolyn Sodium Oral Solution (Concentrate) Cromolyn Sodium Oral Solution (Concentrate) Ritedose Pharmaceuticals, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 50121 ORIG 2017-10-19