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 8 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	95b7de4c-9c69-45f6-9221-a2c87c441b04	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Bryant Ranch Prepack	419058f7-7f30-41a1-964b-8eaa69290dea	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	b42adc18-21cc-4fe0-bf7d-fb76f4cda215	2025-10-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	bfcc98b8-184e-4db4-8079-de88958c774b	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	aba52f0c-0706-46ac-957d-e53963d35499	2025-09-26	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Coupler LLC	3e0e3e28-e6ff-7b48-e063-6294a90a9acd	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	Granulation Technology, Inc.	a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	28130e6d-7cda-459a-9f80-cacaa82d71d3	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	f4500eb6-d24a-4247-83f4-99e73346e328	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	dc94273f-af06-4bd5-9ce3-ce0a0f36587b	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	27d8dcad-a024-ed85-e063-6394a90a420d	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	Bryant Ranch Prepack	136b98cd-60aa-4dc3-966c-488f4b7d6117	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	48ee895b-dc3a-4f1f-8688-e06c217f449b	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	08973b30-8576-4d31-aeef-934b72124e1f	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PREDNISONE	PREDNISONE	Preferred Pharmaceuticals Inc.	60bb6698-d1fc-4720-9954-266a3d650f0d	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: PREDNISONE generic name: PREDNISONE
Prednisone	PREDNISONE	Bryant Ranch Prepack	0b2c2085-c4da-4441-ae5e-eefe26fd199e	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	263ed4fa-3c29-4abb-9cb1-bc016bd34a05	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
PredniSONE	PREDNISONE	Hikma Pharmaceuticals USA Inc.	3115aef0-fd50-4ec8-a064-3effb695f3f2	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: PredniSONE generic name: PREDNISONE
prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	2d0562ad-6175-833c-e063-6394a90ad029	2025-04-04	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.