Application 040189

Type: ANDA
Sponsor: JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	TABLET;ORAL	4MG	No	No
002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	TABLET;ORAL	8MG	No	No
003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	TABLET;ORAL	16MG	No	No
004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	TABLET;ORAL	32MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040189-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31
A040189-002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31
A040189-003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20
A040189-004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A040189-001	AB
A040189-002	AB
A040189-003	AB
A040189-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040189-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	1997-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2007-07-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A040189-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040189-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040189-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040189-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040189-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040189-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040189-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040189-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040189-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040189-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040189-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040189-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040189-004	AB	1	`d06236e962d9…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f3676-856f-e8d7-e053-2995a90ad703	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189
Methylprednisolone	METHYLPREDNISOLONE	A-S Medication Solutions	eb479561-142d-410c-84b2-988375c6a96e	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189 ndc (product): 50090-3094
Methylprednisolone	METHYLPREDNISOLONE	Proficient Rx LP	283a913e-f737-478e-b6a0-e050fb6562d8	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189 ndc (product): 63187-160
Methylprednisolone	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040189 application number: ANDA040189 ndc (product): 76420-041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-080	Methylprednisolone	Methylprednisolone	Rebel Distributors Corp.	ANDA	Current
33261-335	Methylprednisolone	Methylprednisolone	Aidarex Pharmaceuticals LLC	ANDA	Current
45865-417	Methylprednisolone	Methylprednisolone	Medsource Pharmaceuticals	ANDA	Current
50090-3094	Methylprednisolone	Methylprednisolone	A-S Medication Solutions	ANDA	Current
50090-3094	Methylprednisolone	Methylprednisolone	A-S Medication Solutions	ANDA	Current
50436-0001	Methylprednisolone	Methylprednisolone	Unit Dose Services	ANDA	Current
50436-4037	Methylprednisolone	Methylprednisolone	Unit Dose Services	ANDA	Current
53002-3120	Methylprednisolone	Methylprednisolone	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3120	Methylprednisolone	Methylprednisolone	RPK Pharmaceuticals, Inc.	ANDA	Current
59746-001	Methylprednisolone	Methylprednisolone	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-002	Methylprednisolone	Methylprednisolone	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-003	Methylprednisolone	Methylprednisolone	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-015	Methylprednisolone	Methylprednisolone	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
61919-149	Methylprednisolone	Methylprednisolone	DIRECT RX	ANDA	Current
61919-149	Methylprednisolone	Methylprednisolone	DIRECT RX	ANDA	Current
63187-160	Methylprednisolone	Methylprednisolone	Proficient Rx LP	ANDA	Current
63187-160	Methylprednisolone	Methylprednisolone	Proficient Rx LP	ANDA	Current
63629-2433	Methylprednisolone	Methylprednisolone	Bryant Ranch Prepack	ANDA	Current
63629-2433	Methylprednisolone	Methylprednisolone	Bryant Ranch Prepack	ANDA	Current
63629-3910	Methylprednisolone	Methylprednisolone	Bryant Ranch Prepack	ANDA	Current
68001-005	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-005	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-005	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-005	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-557	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-557	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-558	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-558	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-559	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-559	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-560	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68001-560	Methylprednisolone	Methylprednisolone	BluePoint Laboratories	ANDA	Current
68071-4028	Methylprednisolone	Methylprednisolone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4028	Methylprednisolone	Methylprednisolone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-4593	Methylprednisolone	Methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-4593	Methylprednisolone	Methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-4593	Methylprednisolone	Methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-4593	Methylprednisolone	Methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-4593	Methylprednisolone	Methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
69306-004	Methylprednisolone	Methylprednisolone	Doc Rx	ANDA	Current
69306-004	Methylprednisolone	Methylprednisolone	Doc Rx	ANDA	Current
70518-2982	Methylprednisolone	Methylprednisolone	REMEDYREPACK INC.	ANDA	Current
70786-0001	Methylprednisolone	Methylprednisolone	Unit Dose Services	ANDA	Current
76420-041	Methylprednisolone	Methylprednisolone	Asclemed USA, Inc.	ANDA	Current
76420-041	Methylprednisolone	Methylprednisolone	Asclemed USA, Inc.	ANDA	Current