Application 208412

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	10MG	No	No
002	PREDNISONE	PREDNISONE	TABLET;ORAL	20MG	No	No
003	PREDNISONE	PREDNISONE	TABLET;ORAL	50MG	No	No
004	PREDNISONE	PREDNISONE	TABLET;ORAL	2.5MG	No	No
005	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208412-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11
A208412-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11
A208412-003	PREDNISONE	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11
A208412-004	PREDNISONE	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20
A208412-005	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208412-001	AB
A208412-002	AB
A208412-003	AB
A208412-004	AB
A208412-005	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 4 · 136 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
2026-09-14 22:38:34	2026-08	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	PREDNISONE	10MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	PREDNISONE	20MG	TABLET / ORAL	AB	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	PREDNISONE	50MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	PREDNISONE	2.5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	PREDNISONE	5MG	TABLET / ORAL	AB	2020-11-20	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208412-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208412-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208412-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208412-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208412-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208412-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208412-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208412-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208412-005	AB	1	`03ed91905a0d…`

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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	A-S Medication Solutions	f4cc64f8-781f-437a-a4a7-2d163026d1c2	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Bryant Ranch Prepack	4433a882-ff79-4a9d-8db8-1977c5cd04cf	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412 ndc (product): 71335-2079
prednisone	PREDNISONE	Bryant Ranch Prepack	a2ba1a31-9e2d-4c1e-9bbd-b813831ce08f	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412 ndc (product): 71335-2069
prednisone	PREDNISONE	A-S Medication Solutions	c7c3bb80-73b6-4128-aa5f-0d465a1d84e8	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	db4a13ff-546d-15b7-e053-2a95a90a6adf	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412 ndc (product): 68071-2661
prednisone	PREDNISONE	Medsource Pharmaceuticals	131780a0-31f3-6588-e063-6294a90a2f8e	2024-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412
prednisone	PREDNISONE	Proficient Rx LP	22d9fd96-cad5-4762-9a56-0ff63357ed9e	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208412 application number: ANDA208412

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 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60760-790	prednisone	PREDNISONE	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
64380-784	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-784	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-784	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-784	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-784	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-785	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-785	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-785	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-785	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-785	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
64380-949	prednisone	PREDNISONE	Strides Pharma Science Limited	ANDA	Current
68071-2661	PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2696	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2771	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2771	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2781	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2781	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2781	prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8166	prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3401	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3401	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3401	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3476	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3476	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3476	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
70518-3555	prednisone	PREDNISONE	REMEDYREPACK INC.	ANDA	Current
71205-729	prednisone	PREDNISONE	Proficient Rx LP	ANDA	Current
71335-2069	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current
71335-2079	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current
71335-2122	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current
71335-2149	prednisone	PREDNISONE	Bryant Ranch Prepack	ANDA	Current