Application 209727

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	2.5MG	No	No
002	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 · 46 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
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209727-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209727-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209727-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209727-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209727-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209727-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209727-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209727-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209727-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209727-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209727-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209727-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209727-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209727-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209727-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209727-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209727-002	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209727-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209727-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209727-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209727-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209727-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209727-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209727-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209727-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209727-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209727-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209727-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209727-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209727-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209727-002	AB	1	`3a93d1ddd44b…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Bryant Ranch Prepack	07d5e455-ac3b-4890-9619-609dd0be9106	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727 ndc (product): 71335-2088
prednisone	PREDNISONE	REMEDYREPACK INC.	e9a74862-6a3b-4247-837a-389761b5c352	2026-04-13	Warnings, Adverse reactions	Exact identifier ndc (product): 70518-3539
prednisone	PREDNISONE	Northwind Health Company, LLC	f2a15b5d-f540-2582-e053-2995a90a591a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	Strides Pharma Science Limited	52010a34-aadb-4561-ac4a-3ee53f5e3566	2025-12-10	Warnings, Adverse reactions	Exact identifier ndc (product): 64380-835 ndc (product): 64380-783
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727 ndc (product): 68788-8184
prednisone	PREDNISONE	Bryant Ranch Prepack	f0354431-4968-4e34-969b-6985d73700a4	2025-02-25	Warnings, Adverse reactions	Exact identifier ndc (product): 71335-2134
Prednisone	PREDNISONE	Direct_Rx	26194836-90c9-6909-e063-6294a90a6f98	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	A-S Medication Solutions	d40a97f6-60d1-4dbc-b4dc-650d82af5fae	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727
prednisone	PREDNISONE	A-S Medication Solutions	17278e0a-cbff-4a95-96ee-f34f7466faa0	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209727 application number: ANDA209727 ndc (product): 50090-5814

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5814	prednisone	PREDNISONE	A-S Medication Solutions	ANDA	Current
50090-5816	prednisone	PREDNISONE	A-S Medication Solutions	ANDA	Current
64380-783	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-783	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-783	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-783	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-835	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-835	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-835	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-835	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
68788-8184	prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3539	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
71335-2088	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current
71335-2134	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current