Application 211575

Type: ANDA
Sponsor: NOVITIUM 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
003	PREDNISONE	PREDNISONE	TABLET;ORAL	10MG	No	No
004	PREDNISONE	PREDNISONE	TABLET;ORAL	20MG	No	No
005	PREDNISONE	PREDNISONE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211575-001	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15
A211575-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15
A211575-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15
A211575-004	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15
A211575-005	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A211575-001	AB
A211575-002	AB
A211575-003	AB
A211575-004	AB
A211575-005	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 5 · 195 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
2026-08-18 06:07:40	2026-07	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-001	PREDNISONE	2.5MG	TABLET / ORAL	AB	2019-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-002	PREDNISONE	5MG	TABLET / ORAL	AB	2019-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-003	PREDNISONE	10MG	TABLET / ORAL	AB	2019-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-004	PREDNISONE	20MG	TABLET / ORAL	AB	2019-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-005	PREDNISONE	50MG	TABLET / ORAL	AB	2019-11-15	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 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	A211575-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211575-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211575-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211575-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211575-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211575-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211575-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211575-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211575-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211575-005	AB	1	`2680178bc6a6…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	19fdbf9f-3a64-b9fa-e063-6394a90af086	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1a9f00ac-ec92-4d2c-e063-6394a90ac4f6	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	25b5958b-c151-9200-e063-6394a90af52c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	1349a022-639b-4494-99a2-1594c7c0f0e9	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	ANI Pharmaceuticals, Inc.	f05eb734-07e7-491c-b2e9-aae340e03750	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 70954-061 ndc (product): 70954-058 ndc (product): 70954-060 ndc (product): 70954-057 ndc (product): 70954-059
Prednisone	PREDNISONE	St. Mary's Medical Park Pharmacy	1b3ea4cc-5bc6-ae47-e063-6294a90af13d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Aphena Pharma Solutions - Tennessee, LLC	18818282-68aa-82e9-e063-6394a90aef54	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone D/P	PREDNISONE D/P	Direct_Rx	4f0a3946-025c-798a-e063-6294a90a831b	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Northwind Health Company, LLC	fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Marlex Pharmaceuticals, Inc.	f499197b-b9b7-1707-e053-2a95a90a0932	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Proficient Rx LP	08973b30-8576-4d31-aeef-934b72124e1f	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	30956dd5-fe19-d5a9-e063-6394a90a2549	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	NuCare Pharmaceuticals, Inc.	31cfc21f-726b-ae80-e063-6294a90a9af4	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	Bryant Ranch Prepack	c60a07f9-ed9f-4434-a69d-2e2fea4843fd	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 71335-2160
Prednisone	PREDNISONE	Bryant Ranch Prepack	7ea7f6a9-78ef-42fe-baac-f817da3976fb	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 71335-1780
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1b42449a-2be8-e4fb-e063-6394a90aff98	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	1c33879e-8b2b-5843-e063-6294a90adea4	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575
Prednisone	PREDNISONE	A-S Medication Solutions	8f7a38c7-7bf9-4951-b529-947cc9a57d6a	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 50090-6225
Prednisone	PREDNISONE	Proficient Rx LP	71d70ec6-859a-4951-af98-248a864e1135	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 71205-421
Prednisone	PREDNISONE	Proficient Rx LP	67681e4e-3002-4428-af5e-6ff1a950b037	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211575 application number: ANDA211575 ndc (product): 71205-407

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-768	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-768	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-769	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-769	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-770	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-770	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-771	Prednisone	Prednisone	AvKARE	ANDA	Current
42291-771	Prednisone	Prednisone	AvKARE	ANDA	Current
50090-6225	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
67296-1419	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
70518-3142	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-3142	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-3142	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70954-057	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-057	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-057	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-058	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-058	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-058	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-059	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-059	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-059	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-060	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-060	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-060	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-061	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-061	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
70954-061	Prednisone	Prednisone	Novitium Pharma LLC	ANDA	Current
71205-407	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-407	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-407	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-407	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-421	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71205-665	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
71335-1780	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-1780	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-2160	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current