Application 213386

Type: ANDA
Sponsor: AMNEAL

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

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
A213386-001	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		2020-06-24
A213386-002	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB		2020-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213386-001	AB
A213386-002	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	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213386-001	PREDNISONE	10MG	TABLET / ORAL	AB	2020-06-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213386-002	PREDNISONE	20MG	TABLET / ORAL	AB	2020-06-24	`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	A213386-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213386-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213386-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213386-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213386-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213386-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213386-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213386-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213386-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213386-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213386-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213386-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213386-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213386-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213386-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213386-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213386-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213386-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213386-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213386-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213386-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213386-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213386-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213386-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213386-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213386-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213386-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213386-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213386-002	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	REMEDYREPACK INC.	e47a0448-331f-4846-8e63-c52c3afa274b	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 70518-3540
prednisone	PREDNISONE	Unit Dose Solutions, Inc.	5590d36d-dbe7-1c78-e063-6294a90ad2d4	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	03228706-92b9-43c9-8d73-c73aa124c58d	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 60219-1708 ndc (product): 60219-1707
prednisone	PREDNISONE	Redpharm Drug	0ab0e81c-8170-6805-e063-6294a90adfc0	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	e28359cf-0c21-487a-a1a3-d1c62cef88f9	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 50090-6123
prednisone	PREDNISONE	A-S Medication Solutions	8f9a581c-5fef-4089-aa94-7dc81ec5b566	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 50090-6122
prednisone	PREDNISONE	A-S Medication Solutions	871540d3-39c3-460c-a855-3aeabfd87267	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 50090-6259
prednisone	PREDNISONE	REMEDYREPACK INC.	4750028a-30ad-420a-8e6b-06dc2429d433	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	81cef50e-394a-49b3-8723-28df68a742d6	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	A-S Medication Solutions	aaea2307-7893-48e9-af64-26172d08d4e8	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	NCS HealthCare of KY, LLC dba Vangard Labs	7b60255f-7d0b-4f91-a75c-6682ac446f6b	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386 ndc (product): 0615-8440 ndc (product): 0615-8441
prednisone	PREDNISONE	Proficient Rx LP	6a0c1192-8ce4-466d-a0f3-d878d67349cf	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386
prednisone	PREDNISONE	Proficient Rx LP	6ec5b58c-65e9-47ee-b2ac-7d0b395a0630	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213386 application number: ANDA213386

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8440	prednisone	prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8441	prednisone	prednisone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50090-6122	prednisone	prednisone	A-S Medication Solutions	ANDA	Current
50090-6123	prednisone	prednisone	A-S Medication Solutions	ANDA	Current
50090-6259	prednisone	prednisone	A-S Medication Solutions	ANDA	Current
60219-1707	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1707	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1707	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1707	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1708	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1708	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1708	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1708	prednisone	prednisone	Amneal Pharmaceuticals NY LLC	ANDA	Current
68788-8212	prednisone	prednisone	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3540	prednisone	prednisone	REMEDYREPACK INC.	ANDA	Current