Application 211495

Type: ANDA
Sponsor: GENEYORK PHARMS

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 · 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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL		2018-12-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211495-002	PREDNISONE	5MG	TABLET / ORAL		2018-12-07	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211495-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2018-12-07	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211495-002	PREDNISONE	5MG	TABLET / ORAL	AB	2018-12-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211495-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211495-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211495-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211495-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211495-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211495-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211495-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211495-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211495-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211495-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211495-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211495-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211495-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211495-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211495-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211495-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211495-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211495-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211495-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211495-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211495-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211495-002	AB	1	`b00525d2431f…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211495-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211495-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211495-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211495-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211495-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211495-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211495-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211495-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211495-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211495-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211495-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211495-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211495-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Chartwell RX, LLC	36631112-3abb-4003-886b-9fe6d9cbe2cc	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211495 application number: ANDA211495

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 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-2931	PREDNISONE	Prednisone	Lannett Company, Inc.	ANDA	Current
0527-2931	PREDNISONE	Prednisone	Lannett Company, Inc.	ANDA	Current
0527-2932	PREDNISONE	Prednisone	Lannett Company, Inc.	ANDA	Current
0527-2932	PREDNISONE	Prednisone	Lannett Company, Inc.	ANDA	Current
60760-932	PREDNISONE	Prednisone	St. Mary's Medical Park Pharmacy	ANDA	Current
68071-2500	PREDNISONE	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5196	PREDNISONE	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5196	PREDNISONE	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8108	PREDNISONE	Prednisone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8108	PREDNISONE	Prednisone	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2675	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2675	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2675	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2676	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2676	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2676	PREDNISONE	Prednisone	REMEDYREPACK INC.	ANDA	Current
70934-647	PREDNISONE	Prednisone	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-699	PREDNISONE	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-537	PREDNISONE	Prednisone	Proficient Rx LP	ANDA	Current
71329-107	PREDNISONE	Prednisone	GeneYork Pharmaceuticals	ANDA	Current
71329-107	PREDNISONE	Prednisone	GeneYork Pharmaceuticals Group LLC	ANDA	Current
71329-108	PREDNISONE	Prednisone	GeneYork Pharmaceuticals	ANDA	Current
71329-108	PREDNISONE	Prednisone	GeneYork Pharmaceuticals Group LLC	ANDA	Current
71335-1524	PREDNISONE	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1628	PREDNISONE	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1628	PREDNISONE	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1737	PREDNISONE	Prednisone	Bryant Ranch Prepack	ANDA	Current
72189-275	PREDNISONE	PREDNISONE	DIRECT RX	ANDA	Current