Application 040888

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 40MG BASE/VIAL	No	No
002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	No	No
003	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
004	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
005	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18
A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18
A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18
A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18
A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040888-001	AP
A040888-002	AP
A040888-003	AP
A040888-004	AP
A040888-005	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.

Product history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-003	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-004	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-005	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-18	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A040888-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-003	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-004	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040888-005	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040888-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040888-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040888-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040888-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040888-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040888-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040888-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040888-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040888-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040888-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040888-005	AP	1	`b8a1b40f171c…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	38698075-ac58-b5a4-e063-6294a90a7848	2025-07-18	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone sodium succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Dr. Reddy's Laboratories Inc	738753c7-507d-4881-5194-02dd7597768b	2024-06-17	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone sodium succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	6a26a977-95dd-cdae-e053-2a91aa0a8b0a	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	dd2bfa31-9eae-2baa-e053-2a95a90a9db7	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	b635e21b-d68d-f60b-e053-2995a90a0f46	2023-05-08	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Fresenius Kabi USA, LLC	c5d22210-73c6-4697-a267-75e243508642	2023-03-02	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-807	Methylprednisolone Sodium Succinate	Methylprednisolone Sodium Succinate	Sagent Pharmaceuticals	ANDA	Current
25021-808	Methylprednisolone Sodium Succinate	Methylprednisolone Sodium Succinate	Sagent Pharmaceuticals	ANDA	Current
25021-810	Methylprednisolone Sodium Succinate	Methylprednisolone Sodium Succinate	Sagent Pharmaceuticals	ANDA	Current