Application 011856

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 40MG BASE/VIAL	Yes	Yes
004	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	Yes	Yes
005	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes
006	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
007	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N011856-003	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-004	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-005	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-006	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N011856-007	SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011856-003	AP
N011856-004	AP
N011856-005	AP
N011856-006	AP
N011856-007	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 · 215 observed 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	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-003	SOLU-MEDROL	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-004	SOLU-MEDROL	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-005	SOLU-MEDROL	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-006	SOLU-MEDROL	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-007	SOLU-MEDROL	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1985-02-27	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N011856-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011856-007	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011856-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011856-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011856-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011856-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011856-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011856-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011856-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011856-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-005	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011856-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-005	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011856-007	AP	1	`03ed91905a0d…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Sportpharm LLC	0cb0ba76-067f-46c4-a5d8-b585d5ecafe3	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	68ef8ec4-16de-4a8c-8696-b09359660380	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 55154-3944
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	7271310c-7764-4812-aa30-a5e90987c7a9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	ea2f9b6f-2375-40a6-8b97-b607b9f3ac63	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	A-S Medication Solutions	8e5997ed-f4a5-43f7-abbd-c8e2219fe0e9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	2af28649-2553-4bcc-9cb1-c73f7cec76d5	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 55154-3940 ndc (product): 55154-3941
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	decceb81-e922-4b72-a278-3ed80f4adb04	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	REMEDYREPACK INC.	1d5ef347-2e9a-432f-9a88-a7c4ba300267	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 70518-2023
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	7e38b09c-da41-4ee3-8f99-812d3276d551	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 55154-3939
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	42df21df-9284-4505-e063-6294a90a7024	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	cd99be87-c8d9-48d6-a8e5-e081052e3f19	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	38698075-ac58-b5a4-e063-6294a90a7848	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856
SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	HF Acquisition Co LLC, DBA HealthFirst	99b3c99a-79d5-6c54-e053-2a95a90a28bc	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 51662-1483
SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	74e5060c-8426-1b77-e053-2a91aa0a1f13	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 51662-1264
SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	74e448ed-f4b4-8d09-e053-2991aa0a7500	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 51662-1263
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	6a26a977-95dd-cdae-e053-2a91aa0a8b0a	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 71872-7061
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	dd2bfa31-9eae-2baa-e053-2a95a90a9db7	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 71872-7085
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	b635e21b-d68d-f60b-e053-2995a90a0f46	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011856 application number: NDA011856 ndc (product): 71872-7232

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 2 of 2 · 135 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1263	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1264	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1264	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1264	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1264	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1264	SOLU-MEDROL	SOLU-MEDROL	HF Acquisition Co. LLC, DBA HealthFirst	NDA	Current
51662-1483	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1483	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-039	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
52584-047	Solu-Medrol	Methylprednisolone Sodium Succinate	General Injectables & Vaccines, Inc	NDA	Current
55154-3939	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3939	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3939	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3939	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3940	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3941	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3944	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health 107, LLC	NDA	Current
55154-3944	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
55154-3944	Solu-Medrol	methylprednisolone sodium succinate	Cardinal Health	NDA	Current
61699-0047	SOLU-MEDROL	methylprednisolone sodium succinate	US MedSource, LLC	NDA	Current
68071-1792	SOLU-MEDROL	methylprednisolone sodium succinate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-1792	SOLU-MEDROL	methylprednisolone sodium succinate	NuCare Pharmaceuticals,Inc.	NDA	Current
70385-2016	SOLU-MEDROL	methylprednisolone sodium succinate	Sina Health Inc	NDA	Current
70518-0334	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-1424	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
70518-2023	SOLU-MEDROL	methylprednisolone sodium succinate	REMEDYREPACK INC.	NDA	Current
71872-7061	SOLU-MEDROL	methylprednisolone sodium succinate	Medical Purchasing Solutions, LLC	NDA	Current
71872-7061	SOLU-MEDROL	methylprednisolone sodium succinate	Medical Purchasing Solutions, LLC	NDA	Current
71872-7085	SOLU-MEDROL	methylprednisolone sodium succinate	Medical Purchasing Solutions, LLC	NDA	Current
71872-7232	SOLU-MEDROL	methylprednisolone sodium succinate	Medical Purchasing Solutions, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84121	SUPPL	2025-11-07
84068	SUPPL	2025-11-05
78708	SUPPL	2024-06-07
78675	SUPPL	2024-06-06
77123	SUPPL	2023-12-22
77105	SUPPL	2023-12-21
69419	SUPPL	2021-11-29
67701	SUPPL	2021-06-04
67628	SUPPL	2021-05-28
54998	SUPPL	2018-07-26
54963	SUPPL	2018-07-25
53584	SUPPL	2018-04-01
53571	SUPPL	2018-04-01
45263	SUPPL	2016-09-09
45262	SUPPL	2016-09-09
45250	SUPPL	2016-09-09
45249	SUPPL	2016-09-09
33063	SUPPL	2014-07-09
11971	SUPPL	2014-07-07
33061	SUPPL	2011-10-25
11969	SUPPL	2011-10-25
10784	SUPPL	2011-10-25
291	SUPPL	2011-10-25
33062	SUPPL	2010-07-01
11970	SUPPL	2010-06-28