Application 204867

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET, DELAYED RELEASE;ORAL	1MG	No	No
002	PREDNISONE	PREDNISONE	TABLET, DELAYED RELEASE;ORAL	2MG	No	No
003	PREDNISONE	PREDNISONE	TABLET, DELAYED RELEASE;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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204867-001	PREDNISONE	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	2017-04-25
A204867-002	PREDNISONE	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL	2017-04-25
A204867-003	PREDNISONE	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL	2017-04-25

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 · 129 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	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL		2017-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-002	PREDNISONE	2MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-003	PREDNISONE	5MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204867-001	PREDNISONE	1MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-04-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204867-003	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A204867-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204867-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204867-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204867-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204867-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204867-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204867-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204867-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204867-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204867-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204867-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204867-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204867-003	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A204867-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204867-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204867-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204867-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204867-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204867-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204867-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204867-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204867-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204867-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204867-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204867-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204867-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204867-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204867-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204867-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204867-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204867-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204867-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204867-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204867-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204867-001	AB	1	`a72a2bbeb626…`

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 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Bryant Ranch Prepack	290a91e5-22ae-4d62-ab34-39a3117002e2	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	4750028a-30ad-420a-8e6b-06dc2429d433	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	0062fcc7-aa08-4990-9d33-d798725907f1	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	REMEDYREPACK INC.	7db793b4-5768-4e9a-a47b-1ebbfed74001	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PREDNISONE	PREDNISONE	REMEDYREPACK INC.	0993b354-d936-472b-bafc-114f0f81bfb0	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE	PREDNISONE	REMEDYREPACK INC.	94715919-70bd-46c9-95fc-e151adf39cf9	2026-08-31	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	23b12d22-97d6-426e-bf9c-dd6c2ff77370	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	6b360c1f-c862-47ee-a40e-3903c2d6162f	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE	PREDNISONE	Preferred Pharmaceuticals Inc.	02158832-550b-4855-a5c5-6abbf13ed6f0	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	c60a07f9-ed9f-4434-a69d-2e2fea4843fd	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	REMEDYREPACK INC.	746b0bcd-122e-4ea8-a824-28415073a38e	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	7ea7f6a9-78ef-42fe-baac-f817da3976fb	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Preferred Pharmaceuticals, Inc.	f89bd1dc-88cd-4aef-a7ae-6310f38a3423	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Major Pharmaceuticals	57b98930-92ab-4b77-a033-ae9895ee718a	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ce7663a7-4c91-4790-aa43-96f259b3bb18	2026-08-19	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	e47a0448-331f-4846-8e63-c52c3afa274b	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
Prednisone	PREDNISONE	Cardinal Health 107, LLC	568b8880-7997-4786-8c57-28816ce52655	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.