FDA.reportPublic FDA data

Application 211304

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METARAMINOL BITARTRATEMETARAMINOL BITARTRATEINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211304-001METARAMINOL BITARTRATEMETARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211304-001METARAMINOL BITARTRATEEQ 10MG BASE/MLINJECTABLE / INJECTION2021-08-24a50c72e98297…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68520ORIG2021-09-02