Application 206751

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A206751-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23
A206751-002	METHYLPREDNISOLONE	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23
A206751-003	METHYLPREDNISOLONE	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23
A206751-004	METHYLPREDNISOLONE	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206751-001	AB
A206751-002	AB
A206751-003	AB
A206751-004	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	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206751-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-002	METHYLPREDNISOLONE	8MG	TABLET / ORAL	AB	2018-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-003	METHYLPREDNISOLONE	16MG	TABLET / ORAL	AB	2018-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-004	METHYLPREDNISOLONE	32MG	TABLET / ORAL	AB	2018-04-23	`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	A206751-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206751-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206751-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206751-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206751-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206751-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206751-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206751-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206751-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206751-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206751-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206751-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206751-004	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methylprednisolone	METHYLPREDNISOLONE	BluePoint Laboratories	7092df48-4904-4047-9916-e585417a216f	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751
methylprednisolone	METHYLPREDNISOLONE	A-S Medication Solutions	646bb826-8d5a-4b03-adfb-ed45daa86d44	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751 ndc (product): 50090-3811
methylprednisolone	METHYLPREDNISOLONE	Major Pharmaceuticals	3885151c-963e-4d22-b5b4-58968503ad8c	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751 ndc (product): 0904-6914
methylprednisolone	METHYLPREDNISOLONE	Zydus Pharmaceuticals USA Inc.	eaa9c932-c659-4ef6-bf5a-186545d87320	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751 ndc (product): 68382-917 ndc (product): 68382-919 ndc (product): 68382-916 ndc (product): 68382-918
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f6120-3c25-2a28-e053-2a95a90a86d5	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751
methylprednisolone	METHYLPREDNISOLONE	Zydus Lifesciences Limited	fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee	2024-12-05		Exact identifier application applno (ANDA): 206751 application number: ANDA206751 ndc (product): 70771-1350 ndc (product): 70771-1349 ndc (product): 70771-1351 ndc (product): 70771-1348
methylprednisolone	METHYLPREDNISOLONE	Proficient Rx LP	177fd649-4339-4bfd-bd12-7e8de302412b	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206751 application number: ANDA206751

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6914	methylprednisolone	methylprednisolone	Major Pharmaceuticals	ANDA	Current
0904-6914	methylprednisolone	methylprednisolone	Major Pharmaceuticals	ANDA	Current
50090-3811	methylprednisolone	methylprednisolone	A-S Medication Solutions	ANDA	Current
50090-3811	methylprednisolone	methylprednisolone	A-S Medication Solutions	ANDA	Current
68071-2745	methylprednisolone	methylprednisolone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-916	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-916	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-916	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-917	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-917	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-917	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-918	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-918	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-918	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-919	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-919	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-919	methylprednisolone	methylprednisolone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68788-7655	methylprednisolone	methylprednisolone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8276	methylprednisolone	methylprednisolone	Preferred Pharmaceuticals Inc.	ANDA	Current
70771-1348	methylprednisolone	methylprednisolone	Zydus Lifesciences Limited	ANDA	Current
70771-1348	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1348	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1348	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1349	methylprednisolone	methylprednisolone	Zydus Lifesciences Limited	ANDA	Current
70771-1349	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1349	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1349	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1350	methylprednisolone	methylprednisolone	Zydus Lifesciences Limited	ANDA	Current
70771-1350	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1350	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1350	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1351	methylprednisolone	methylprednisolone	Zydus Lifesciences Limited	ANDA	Current
70771-1351	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1351	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current
70771-1351	methylprednisolone	methylprednisolone	Cadila Healthcare Limited	ANDA	Current