Application 210985

Type: ANDA
Sponsor: NOVAST LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	TABLET;ORAL	4MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210985-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL			2019-01-09

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 2 · 41 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	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2019-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2019-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2019-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210985-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL		2019-01-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210985-001	AB	1	`c0c555d07b60…`
2019-09-15 20:21 UTC	2019-09	A210985-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210985-001	AB	1	`ea99ee380514…`

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYLPREDNISOLONE	METHYLPREDNISOLONE	HAWAII REPACK, INC.	d0d5fc54-69e1-4303-96be-3f97adec6074	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
Methylprednisolone	METHYLPREDNISOLONE	American Health Packaging	97256c7e-5694-4148-926f-594b9d5c34f4	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Preferred Pharmaceuticals Inc.	e27ab941-adc6-47b6-b217-08d095a851fd	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
Methylprednisolone	METHYLPREDNISOLONE	Mylan Pharmaceuticals Inc.	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	St. Mary's Medical Park Pharmacy	235ca8cf-1576-0dfd-e063-6394a90a8b25	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
methylprednisolone	METHYLPREDNISOLONE	BluePoint Laboratories	7092df48-4904-4047-9916-e585417a216f	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE
MethylPREDNISolone	METHYLPREDNISOLONE	Par Health USA, LLC	c84cf5e6-746d-41fb-b3d8-2c0b8ba989af	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: MethylPREDNISolone generic name: METHYLPREDNISOLONE
methylprednisolone	METHYLPREDNISOLONE	A-S Medication Solutions	646bb826-8d5a-4b03-adfb-ed45daa86d44	2026-03-07	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE
Methylprednisolone	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	bdd233d9-333d-7389-e053-2a95a90a4b42	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	REMEDYREPACK INC.	445e59a6-8886-48e7-8116-253a82144934	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Sportpharm LLC	fd9f28a0-fd86-4767-876c-8520fddeccd2	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Tianjin Tianyao Pharmaceuticals Co., Ltd.	e09eefd2-f423-40cb-87b6-3ee97e7f831b	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	PHOENIX RX LLC	476ef50d-7e77-75f6-e063-6294a90a26e4	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma, LLC	b1908c2a-c596-4e2a-b2bd-0745d4fea31a	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE generic name: METHYLPREDNISOLONE
methylprednisolone	METHYLPREDNISOLONE	Major Pharmaceuticals	3885151c-963e-4d22-b5b4-58968503ad8c	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Tianjin Kingyork Pharmaceuticals Co., Ltd	77a8d96c-37df-4f3a-9757-b2d4131ff82b	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Amneal Pharmaceuticals LLC	e86fbda8-00e4-4d54-841a-59dea6c15e70	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE
Medrol	METHYLPREDNISOLONE	Pharmacia & Upjohn Company LLC	39d5270b-d957-4821-93d6-501b7b9f02d4	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE
methylprednisolone	METHYLPREDNISOLONE	Zydus Pharmaceuticals USA Inc.	eaa9c932-c659-4ef6-bf5a-186545d87320	2025-11-10	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone generic name: METHYLPREDNISOLONE
Methylprednisolone	METHYLPREDNISOLONE	REMEDYREPACK INC.	d2a0e52c-f724-40e6-9d2a-5f1487c104b6	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone generic name: METHYLPREDNISOLONE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-189	METHYLPREDNISOLONE	methylprednisolone	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-189	METHYLPREDNISOLONE	methylprednisolone	Ingenus Pharmaceuticals, LLC	ANDA	Current