Application 040611

Type: ANDA
Sponsor: JUBILANT CADISTA

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 43.

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
A040611-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2005-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040611-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040611-001	PREDNISONE	1MG	TABLET / ORAL	AB	2005-06-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040611-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040611-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040611-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040611-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040611-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040611-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040611-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040611-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040611-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040611-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040611-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040611-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040611-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040611-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040611-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040611-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040611-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040611-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040611-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040611-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040611-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040611-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040611-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040611-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040611-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040611-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040611-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040611-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040611-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040611-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040611-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040611-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040611-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040611-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040611-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040611-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040611-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040611-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040611-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040611-001	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Proficient Rx LP	7a92b171-52ca-4948-81fc-e9a30597c5d8	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040611 application number: ANDA040611 ndc (product): 71205-089

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-171	Prednisone	Prednisone	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
63629-2434	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
63629-2434	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
70518-1167	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1167	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
71205-089	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-089	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71335-2153	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current