Application 209467

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLNoYes

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
A209467-001SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209467-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209467-001SUCCINYLCHOLINE CHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2018-05-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209467-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209467-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209467-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209467-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209467-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209467-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209467-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209467-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209467-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209467-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209467-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209467-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209467-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209467-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209467-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209467-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209467-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209467-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209467-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209467-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209467-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209467-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209467-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209467-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209467-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209467-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209467-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209467-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209467-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209467-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209467-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209467-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209467-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209467-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209467-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209467-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209467-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209467-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209467-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209467-001AP1e64feba35796…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEZydus Lifesciences Limitedc7f409ed-e4f4-4cd6-8f37-93f505dd986d2023-10-19Exact identifier
application applno (ANDA): 209467
application number: ANDA209467
ndc (product): 70771-1352
Succinylcholine ChlorideSUCCINYLCHOLINE CHLORIDEZydus Pharmaceuticals USA Inc.017e5ad4-028e-4e34-ac09-d0c8d64c880a2022-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209467
application number: ANDA209467
ndc (product): 70710-1377

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52584-377SUCCINYLCHOLINE CHLORIDEsuccinylcholine chlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-377SUCCINYLCHOLINE CHLORIDEsuccinylcholine chlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
70710-1377Succinylcholine ChlorideSuccinylcholine ChlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1377Succinylcholine ChlorideSuccinylcholine ChlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1377Succinylcholine ChlorideSuccinylcholine ChlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1377Succinylcholine ChlorideSuccinylcholine ChlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1377Succinylcholine ChlorideSuccinylcholine ChlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1352Succinylcholine ChlorideSuccinylcholine ChlorideZydus Lifesciences LimitedANDACurrent
70771-1352Succinylcholine ChlorideSuccinylcholine ChlorideCadila Healthcare LimitedANDACurrent
72785-0010Succinylcholine ChlorideSuccinylcholine ChlorideLiva Pharmaceuticals LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54451ORIG2018-06-05