Application 040584

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040584-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040584-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040584-001	PREDNISONE	1MG	TABLET / ORAL	AB	2004-12-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040584-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040584-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040584-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040584-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040584-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040584-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040584-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040584-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040584-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040584-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040584-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040584-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040584-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040584-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040584-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040584-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040584-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040584-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040584-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040584-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040584-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040584-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040584-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040584-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040584-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040584-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040584-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040584-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040584-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040584-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040584-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040584-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040584-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040584-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040584-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040584-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040584-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040584-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040584-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040584-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Par Health USA, LLC	10fe5a3b-84dc-4600-87c2-b80c97ce18cf	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584 ndc (product): 0603-5335
Prednisone	PREDNISONE	Bryant Ranch Prepack	0062fcc7-aa08-4990-9d33-d798725907f1	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584 ndc (product): 63629-2254
Prednisone	PREDNISONE	Bryant Ranch Prepack	e4c1c8c5-0aa1-4531-aa7a-8567ac8dcba8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584
PREDNISONE	PREDNISONE	DIRECT RX	2a053775-6f6a-455e-b9a8-8b60e6062db3	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584 ndc (product): 61919-365
Prednisone	PREDNISONE	Bryant Ranch Prepack	0b2c2085-c4da-4441-ae5e-eefe26fd199e	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040584 application number: ANDA040584

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-5335	Prednisone	Prednisone	Par Pharmaceutical, Inc.	ANDA	Current
0603-5335	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5335	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5335	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5335	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
10544-274	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
61919-365	PREDNISONE	PREDNISONE	DIRECT RX	ANDA	Current
61919-365	PREDNISONE	PREDNISONE	DIRECT RX	ANDA	Current
61919-365	PREDNISONE	PREDNISONE	DIRECT RX	ANDA	Current
63629-2254	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-2254	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-2255	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-2255	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
70518-2703	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2703	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2703	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current