Home Applications 075172 Application 075172
Type ANDA
Sponsor PADDOCK LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COLOCORT HYDROCORTISONE ENEMA;RECTAL 100MG/60ML 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 A075172-001 COLOCORT HYDROCORTISONE 100MG/60ML ENEMA / RECTAL AB 1999-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075172-001 AB
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 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0574-2020 Colocort Hydrocortisone Paddock Laboratories, LLC ANDA Current 62135-020 Hydrocortisone Rectal Suspension (Retention) Hydrocortisone Chartwell RX, LLC ANDA Current 62135-020 Hydrocortisone Rectal Suspension (Retention) Hydrocortisone Chartwell RX LLC ANDA Current 62135-020 Hydrocortisone Rectal Suspension (Retention) Hydrocortisone Chartwell RX LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30781 ORIG 1999-12-06