Application 204072

Type: ANDA
Sponsor: TIANJIN TIANYAO

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
A204072-001	METHYLPREDNISOLONE	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB		2018-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204072-001	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 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	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204072-001	METHYLPREDNISOLONE	4MG	TABLET / ORAL	AB	2018-05-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204072-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204072-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204072-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204072-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204072-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204072-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204072-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204072-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204072-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204072-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204072-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204072-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204072-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204072-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204072-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204072-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204072-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204072-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204072-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204072-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204072-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204072-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204072-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204072-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204072-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204072-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204072-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204072-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204072-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204072-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204072-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204072-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204072-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204072-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204072-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204072-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204072-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204072-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204072-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204072-001	AB	1	`cb3db0bc1861…`

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 · 14 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	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Preferred Pharmaceuticals Inc.	e27ab941-adc6-47b6-b217-08d095a851fd	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 68788-7833
METHYLPREDNISOLONE	METHYLPREDNISOLONE	St. Mary's Medical Park Pharmacy	235ca8cf-1576-0dfd-e063-6394a90a8b25	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	REMEDYREPACK INC.	445e59a6-8886-48e7-8116-253a82144934	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 70518-2864
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Sportpharm LLC	fd9f28a0-fd86-4767-876c-8520fddeccd2	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Tianjin Tianyao Pharmaceuticals Co., Ltd.	e09eefd2-f423-40cb-87b6-3ee97e7f831b	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 57582-101
METHYLPREDNISOLONE	METHYLPREDNISOLONE	PHOENIX RX LLC	476ef50d-7e77-75f6-e063-6294a90a26e4	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma, LLC	b1908c2a-c596-4e2a-b2bd-0745d4fea31a	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 42806-400
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Direct_Rx	8c3f3f63-8a05-7a4a-e053-2995a90ad95a	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 72189-264
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f4304-bf37-da04-e053-2a95a90a4044	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072
METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	a1dae00d-1ad3-7493-e053-2a95a90af49f	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 68071-5221
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Proficient Rx LP	3e37236f-8ba8-4a1c-87c8-62b787890fae	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 71205-453
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	c6ec50b5-aeb8-40c3-83e2-af4fe8fefb14	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 69306-400
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bff5330-c1f6-4014-aadb-45c1726248dd	2021-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204072 application number: ANDA204072 ndc (product): 76420-193

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma,LLC	ANDA	Current
42806-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma,LLC	ANDA	Current
42806-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma,LLC	ANDA	Current
42806-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Epic Pharma,LLC	ANDA	Current
57582-101	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-101	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
68071-5221	METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5221	METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5221	METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7833	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7833	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Preferred Pharmaceuticals Inc.	ANDA	Current
69306-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	ANDA	Current
69306-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	ANDA	Current
69306-400	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	ANDA	Current
70518-2864	METHYLPREDNISOLONE	METHYLPREDNISOLONE	REMEDYREPACK INC.	ANDA	Current
71205-453	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Proficient Rx LP	ANDA	Current
71205-453	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Proficient Rx LP	ANDA	Current
72189-264	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Direct_Rx	ANDA	Current
76420-193	METHYLPREDNISOLONE	METHYLPREDNISOLONE	Asclemed USA, Inc.	ANDA	Current