Application 040392

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	20MG	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
A040392-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2003-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040392-001	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	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040392-001	PREDNISONE	20MG	TABLET / ORAL	AB	2003-02-12	`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	A040392-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040392-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040392-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040392-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040392-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040392-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040392-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040392-001	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): 040392 application number: ANDA040392 ndc (product): 0603-5339
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-1989
Prednisone	PREDNISONE	Cardinal Health 107, LLC	199ed6a6-d9d9-49de-b383-5933a026591b	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392
Prednisone	PREDNISONE	A-S Medication Solutions	efe0c82b-9dd9-4729-b06f-06307867aca0	2026-01-20	Warnings, Adverse reactions	Exact identifier ndc (product): 50090-1990
Prednisone	PREDNISONE	American Health Packaging	a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040392 application number: ANDA040392 ndc (product): 60687-145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-5339	Prednisone	Prednisone	Par Pharmaceutical, Inc.	ANDA	Current
0603-5339	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5339	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5339	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
0603-5339	Prednisone	Prednisone	Par Pharmaceutical	ANDA	Current
33261-129	Prednisone	Prednisone	Aidarex Pharmaceuticals LLC	ANDA	Current
42708-046	Prednisone	Prednisone	QPharma Inc	ANDA	Current
42708-046	Prednisone	Prednisone	QPharma Inc	ANDA	Current
50090-1989	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-1989	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-1989	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-1990	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-1990	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-1991	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
52959-127	Prednisone	Prednisone	H.J. Harkins Company, Inc.	ANDA	Current
53808-0543	Prednisone	PREDNISONE	State of Florida DOH Central Pharmacy	ANDA	Current
55700-733	Prednisone	Prednisone	Quality Care Products, LLC	ANDA	Current
60687-145	Prednisone	Prednisone	American Health Packaging	ANDA	Current
60687-145	Prednisone	Prednisone	American Health Packaging	ANDA	Current
60687-145	Prednisone	Prednisone	American Health Packaging	ANDA	Current
63629-1587	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-1587	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-7335	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63739-520	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-520	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-520	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
66336-094	Prednisone	Prednisone	Dispensing Solutions, Inc.	ANDA	Current
67296-0600	PREDNISONE	prednisone	RedPharm Drug Inc.	ANDA	Current
70518-2061	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current