Home Applications 212296 Application 212296
Type ANDA
Sponsor SLAYBACK PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEOXYCHOLIC ACID DEOXYCHOLIC ACID SOLUTION;SUBCUTANEOUS 20MG/2ML (10MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A212296-001 DEOXYCHOLIC ACID DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212296-001 AP
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 2026-09-14 22:38:34 2026-08 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212296-001 DEOXYCHOLIC ACID 20MG/2ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-04-02 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 67422 ORIG 2021-05-06