Application 085161

Type: ANDA
Sponsor: WATSON LABS

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
A085161-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A085161-001	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982	`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	A085161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085161-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	A-S Medication Solutions	aaaa3460-0239-4203-857f-0ada303c2108	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 50090-2789
Prednisone	PREDNISONE	A-S Medication Solutions	de498de3-6ee6-4594-895e-cc69f050e34e	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 50090-2804
Prednisone	PREDNISONE	A-S Medication Solutions	a6811c1f-3dad-46bb-b541-fddd2ff8e569	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 50090-2786
Prednisone	PREDNISONE	Northwind Health Company, LLC	f6cb7924-4190-f130-e053-6294a90a21fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161
Prednisone	PREDNISONE	QPharma, Inc.	d898d53f-c7d2-4bdb-bd9e-5f200070d123	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 42708-105
Prednisone	PREDNISONE	Actavis Pharma, Inc.	aa0b1582-6ef3-4697-9ea6-5391e6e57853	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 0591-5443
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	7e541478-4a33-189f-e053-2a91aa0a6962	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 68071-4685
Prednisone	PREDNISONE	Proficient Rx LP	016d65c3-fff2-4e0c-9025-e2083cfa6a1f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085161 application number: ANDA085161 ndc (product): 71205-239

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5443	Prednisone	Prednisone	Actavis Pharma, Inc.	ANDA	Current
0591-5443	Prednisone	Prednisone	Actavis Pharma, Inc.	ANDA	Current
10544-045	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
42708-105	Prednisone	Prednisone	QPharma Inc	ANDA	Current
42708-105	Prednisone	Prednisone	QPharma Inc	ANDA	Current
42708-105	Prednisone	Prednisone	QPharma Inc	ANDA	Current
42708-105	Prednisone	Prednisone	QPharma Inc	ANDA	Current
50090-2786	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-2789	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-2789	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-2789	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-2804	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
53002-3252	Prednisone	Prednisone	RPK Pharmaceuticals, Inc.	ANDA	Current
55154-8130	Prednisone	Prednisone	Cardinal Health	ANDA	Current
55154-8130	Prednisone	Prednisone	Cardinal Health	ANDA	Current
55700-728	Prednisone	Prednisone	Quality Care Products, LLC	ANDA	Current
55700-728	Prednisone	Prednisone	Quality Care Products, LLC	ANDA	Current
61919-326	PREDNISONE	PREDNISONE	Direct_Rx	ANDA	Current
61919-326	PREDNISONE	PREDNISONE	Diect_Rx	ANDA	Current
61919-326	PREDNISONE	PREDNISONE	Direct_Rx	ANDA	Current
61919-326	PREDNISONE	PREDNISONE	Direct_Rx	ANDA	Current
63739-588	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-588	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-588	Prednisone	Prednisone	McKesson Corporation dba SKY Packaging	ANDA	Current
67296-0138	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-0138	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-0138	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-0138	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
68071-4685	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4685	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,In	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4691	Prednisone	Prednisone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7637	Prednisone	Prednisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7637	Prednisone	Prednisone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1561	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1854	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1854	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1854	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-1854	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2073	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2314	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2314	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2314	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2314	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2314	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70934-218	Prednisone	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-218	Prednisone	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-218	Prednisone	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-218	Prednisone	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-674	Prednisone	Prednisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-239	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-239	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-239	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-239	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71335-0857	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-0857	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1285	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1285	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1285	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1294	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1629	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current