Application 080352

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	Yes
002	PREDNISONE	PREDNISONE	TABLET;ORAL	1MG	Yes	Yes
003	PREDNISONE	PREDNISONE	TABLET;ORAL	2.5MG	Yes	Yes
004	PREDNISONE	PREDNISONE	TABLET;ORAL	10MG	Yes	Yes
005	PREDNISONE	PREDNISONE	TABLET;ORAL	20MG	Yes	Yes
006	PREDNISONE	PREDNISONE	TABLET;ORAL	50MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080352-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-002	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22
A080352-003	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22
A080352-004	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-005	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A080352-006	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A080352-001	AB
A080352-002	AB
A080352-003	AB
A080352-004	AB
A080352-005	AB
A080352-006	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 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-002	PREDNISONE	1MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-003	PREDNISONE	2.5MG	TABLET / ORAL	AB	RLD, RS	1982-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-004	PREDNISONE	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-005	PREDNISONE	20MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080352-006	PREDNISONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080352-001	PREDNISONE	5MG	TABLET / ORAL	AB	RS, Approved before 1982		`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A080352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080352-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080352-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080352-006	AB	1	`a50c72e98297…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE	PREDNISONE	St. Mary's Medical Park Pharmacy	16ee689e-c7a9-3a5a-e063-6394a90a6ea2	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Northwind Health Company, LLC	ab315be2-8d13-be25-e053-2995a90a5184	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 51655-355
PredniSONE	PREDNISONE	Northwind Health Company, LLC	c9f4711d-319c-d952-e053-2a95a90a3697	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	REMEDYREPACK INC.	7db793b4-5768-4e9a-a47b-1ebbfed74001	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	f4500eb6-d24a-4247-83f4-99e73346e328	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 43063-968
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 0054-9828
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	3115aef0-fd50-4ec8-a064-3effb695f3f2	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 0054-8724 ndc (product): 0054-4728
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e62cf2e-dcbe-c15e-e063-6294a90a8168	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	Advanced Rx of Tennessee, LLC	2e630aa1-eccd-f5eb-e063-6294a90a4745	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	af861c38-3293-13fe-e053-2995a90a9932	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352 ndc (product): 80425-0068
PredniSONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	1289c6d2-2707-baca-e063-6294a90a750d	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	0060b86b-0b79-4c54-a7be-97683a933a05	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	f11c190e-edf8-454d-82c4-1ed769b5a6d2	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352
PredniSONE	PREDNISONE	A-S Medication Solutions	6f0719a2-1759-4354-9363-bb9fb3bddb3d	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080352 application number: ANDA080352

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 79 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4728	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8724	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-9828	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-9828	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-9828	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-9828	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-9828	PredniSONE	PredniSONE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0463-6155	PredniSONE	PredniSONE	C.O. Truxton, Inc.	ANDA	Current
0615-0536	PredniSONE	PredniSONE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-0536	PredniSONE	Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-0536	PredniSONE	PredniSONE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-0536	PredniSONE	Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-0536	PredniSONE	Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-0536	PredniSONE	PredniSONE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8395	Prednisone	Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8395	Prednisone	Prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
42708-047	Prednisone	Prednisone	QPharma Inc	ANDA	Current
42708-047	Prednisone	Prednisone	QPharma Inc	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-968	PredniSONE	PredniSONE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-657	PredniSONE	PredniSONE	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
43353-657	PredniSONE	PredniSONE	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
50436-4324	PredniSONE	PredniSONE	Unit Dose Services	ANDA	Current
51407-357	PredniSONE	PredniSONE	Golden State Medical Supply	ANDA	Current
51407-357	PredniSONE	PredniSONE	Golden State Medical Supply	ANDA	Current
51407-357	PredniSONE	PredniSONE	Golden State Medical Supply, Inc.	ANDA	Current
51407-357	PredniSONE	PredniSONE	Golden State Medical Supply, Inc.	ANDA	Current
51655-355	PredniSONE	PredniSONE	Northwind Pharmaceuticals	ANDA	Current
51655-355	PredniSONE	PredniSONE	Northwind Pharmaceuticals	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health	ANDA	Current
55154-4938	PredniSONE	PredniSONE	Cardinal Health 107, LLC	ANDA	Current
63629-8119	PredniSONE	PredniSONE	Bryant Ranch Prepack	ANDA	Current
63629-8119	PredniSONE	PredniSONE	Bryant Ranch Prepack	ANDA	Current
67296-1704	PredniSONE	PredniSONE	RedPharm Drug, Inc.	ANDA	Current
67296-1704	PredniSONE	PredniSONE	RedPharm Drug, Inc.	ANDA	Current
68071-2509	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2578	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4862	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4862	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4903	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4903	PredniSONE	PredniSONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1116	PredniSONE	PredniSONE	REMEDYREPACK INC.	ANDA	Current
70518-1116	PredniSONE	PredniSONE	REMEDYREPACK INC.	ANDA	Current
70518-2516	PredniSONE	PredniSONE	REMEDYREPACK INC.	ANDA	Current
70518-2516	PredniSONE	PredniSONE	REMEDYREPACK INC.	ANDA	Current
70934-290	PredniSONE	PredniSONE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-290	PredniSONE	PredniSONE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-290	PredniSONE	PredniSONE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1220	PredniSONE	PredniSONE	Bryant Ranch Prepack	ANDA	Current
71335-1220	PredniSONE	PredniSONE	Bryant Ranch Prepack	ANDA	Current
71610-641	PredniSONE	PredniSONE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0068	Prednisone	Prednisone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0068	Prednisone	Prednisone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current