Application 212396

Type
ANDA
Sponsor
GENEYORK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 40MG BASE/VIALNoNo
002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 125MG BASE/VIALNoNo
003METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
004METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
005METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A212396-001AP
A212396-002AP
A212396-003AP
A212396-004AP
A212396-005AP

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 5 · 165 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212396-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212396-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-005AP15bbf6a4d5a75…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEHF Acquisition Co LLC, DBA HealthFirst559427ac-9fc6-96f5-e063-6294a90a0b302026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.f339882f-c380-4022-bdcd-94556a7926aa2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONETianjin Kingyork Pharmaceuticals Co., Ltd77a8d96c-37df-4f3a-9757-b2d4131ff82b2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
ndc (product): 82094-401
ndc (product): 82094-403
ndc (product): 82094-405
ndc (product): 82094-404
ndc (product): 82094-402
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEDr. Reddy's Laboratories Inc738753c7-507d-4881-5194-02dd7597768b2024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
ndc (product): 43598-128
ndc (product): 43598-130
ndc (product): 43598-129
ndc (product): 43598-127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-127Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-127Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-128Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-128Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-129Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-129Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-130Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-130Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
71329-301Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-302Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-303Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-304Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-305Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
82094-401Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-401Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-402Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-402Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-403Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-403Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-404Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-404Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-405Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-405Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent