Application 213385

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	1MG	No	No
002	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213385-001	PREDNISONE	PREDNISONE	1MG	TABLET / ORAL	AB		2020-06-16
A213385-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB		2020-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213385-001	AB
A213385-002	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 · 76 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	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	PREDNISONE	1MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	PREDNISONE	5MG	TABLET / ORAL	AB	2020-06-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A213385-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213385-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213385-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213385-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213385-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213385-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213385-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213385-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213385-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213385-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213385-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213385-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213385-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213385-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213385-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213385-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213385-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213385-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213385-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213385-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213385-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213385-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213385-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213385-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213385-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213385-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213385-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213385-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213385-002	AB	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	0740ef68-7641-432e-bd46-4710687fc9d7	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385 ndc (product): 60219-1705 ndc (product): 60219-1706
prednisone	PREDNISONE	Northwind Health Company, LLC	e08ba8c5-5e26-6120-e053-2995a90a1364	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385 ndc (product): 51655-988
prednisone	PREDNISONE	A-S Medication Solutions	80705a8a-f007-4a18-82a6-a73733d57ea2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	43a4b2eb-f2cd-410f-9719-577fdc4ad5de	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	A-S Medication Solutions	6f326242-786c-44b5-9317-f5fb0485d8e2	2025-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	bc37cc2e-2f6a-4131-bb6a-63b6e576df21	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213385 application number: ANDA213385 ndc (product): 0615-8439

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8439	prednisone	prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
51655-988	prednisone	prednisone	Northwind Pharmaceuticals	ANDA	Current
60219-1705	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1705	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1706	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1706	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
68788-8267	prednisone	prednisone	Preferred Pharmaceuticals Inc.	ANDA	Current