Application 011757

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	40MG/ML	Yes	Yes
002	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	20MG/ML	Yes	Yes
004	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	80MG/ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N011757-001	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982
N011757-002	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N011757-004	DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N011757-001	AB
N011757-004	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-002	DEPO-MEDROL	20MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-004	DEPO-MEDROL	80MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011757-001	DEPO-MEDROL	40MG/ML	INJECTABLE / INJECTION	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011757-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011757-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011757-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011757-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011757-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011757-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011757-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011757-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011757-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011757-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011757-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011757-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011757-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011757-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011757-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011757-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011757-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011757-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011757-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011757-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011757-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011757-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011757-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011757-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011757-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011757-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011757-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011757-004	AB	1	`74a2ff9319b5…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	823b0010-2b57-4e76-b5ac-4a8c2963438f	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 0009-0306 ndc (product): 0009-0274 ndc (product): 0009-0280
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	9a7b3837-e038-48bf-97e9-78ad463760dc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 0009-3475 ndc (product): 0009-3073
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	bf1b104d-85cb-414d-a366-78068c82c883	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 0009-3475 ndc (product): 0009-3073
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	cb457bef-8823-4f3c-987b-eb0922494c46	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 50090-2098
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	d75f6751-9ac3-416f-8470-6c011aacf755	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 50090-0436
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	e8209047-c1e6-4081-a6d3-c603d9ee4f14	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 50090-1823
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	aa151d12-bd33-4d26-848f-2195172c9700	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757 ndc (product): 50090-0556
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Asclemed USA, Inc.	cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011757 application number: NDA011757

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0274	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0274	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0274	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0274	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0280	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0280	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0280	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0280	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0280	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0306	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0306	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0306	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0306	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-0306	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3073	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-3475	Depo-Medrol	methylprednisolone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
21695-952	Depo-Medrol	methylprednisolone acetate	Rebel Distributors Corp	NDA	Current
49836-010	P-Care D40MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-010	P-Care D40MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-010	P-Care D40MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-011	P-Care D40	methylprednisolone acetate, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-011	P-Care D40	methylprednisolone acetate, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-011	P-Care D40	methylprednisolone acetate, povidone-iodine, isopropyl alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-012	P-Care D40G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-012	P-Care D40G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-012	P-Care D40G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-013	P-Care D80MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-013	P-Care D80MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-013	P-Care D80MX	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl	RX PHARMA-PACK, INC.	NDA	Current
49836-014	P-Care D80	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-014	P-Care D80	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-014	P-Care D80	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-015	P-Care D80G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-015	P-Care D80G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
49836-015	P-Care D80G	Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol	RX PHARMA-PACK, INC.	NDA	Current
50090-0312	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0312	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0312	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0436	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0436	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0436	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0556	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0556	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-0556	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-1823	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-1823	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-1823	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-2098	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-2098	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-2098	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
50090-2098	Depo-Medrol	methylprednisolone acetate	A-S Medication Solutions	NDA	Current
55045-3243	Depo-Medrol	methylprednisolone acetate	Dispensing Solutions, Inc.	NDA	Current
55154-3929	Depo-Medrol	methylprednisolone acetate	Cardinal Health	NDA	Current
55154-3932	Depo-Medrol	methylprednisolone acetate	Cardinal Health	NDA	Current
63187-350	Multi-Specialty Kit	Depo-Medrol, Lidocaine, Isopropyl Alcohol	Proficient Rx LP	NDA	Current
63874-413	Methylprednisolone	methylprednisolone	Altura Pharmaceuticals, Inc.	NDA	Current
70518-0516	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-0516	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-0516	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-0516	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-1088	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-2148	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-2148	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-2148	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70518-2148	Depo-Medrol	methylprednisolone acetate	REMEDYREPACK INC.	NDA	Current
70859-037	Point Of Care L2	Depo-Medrol, Lidocaine HCI, Isopropyl Alcohol	NuCare Pharmaceuticals,Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84123	SUPPL	2025-11-07
84067	SUPPL	2025-11-05
78707	SUPPL	2024-06-07
78674	SUPPL	2024-06-06
77122	SUPPL	2023-12-22
77104	SUPPL	2023-12-21
67702	SUPPL	2021-06-04
67629	SUPPL	2021-05-28
66223	SUPPL	2021-02-16
66208	SUPPL	2021-02-16
64124	SUPPL	2020-07-29
54997	SUPPL	2018-07-26
54964	SUPPL	2018-07-25
47598	SUPPL	2017-03-20
45261	SUPPL	2016-09-09
45251	SUPPL	2016-09-09
10778	SUPPL	2014-07-09
285	SUPPL	2014-07-08
33055	SUPPL	2009-04-16
11958	SUPPL	2009-04-16
11957	SUPPL	2009-04-16
10777	SUPPL	2009-04-16