Application 080209

Type: ANDA
Sponsor: CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080209-001	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL		Approved before 1982

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080209-001	PREDNISONE	5MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`

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 · 245 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	fa75f5ce-8a74-4873-811f-7d9d9beec08f	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	ce7663a7-4c91-4790-aa43-96f259b3bb18	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: prednisone generic name: PREDNISONE
prednisone	PREDNISONE	Preferred Pharmaceuticals Inc.	930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: prednisone 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	PREDNISONE	REMEDYREPACK INC.	4750028a-30ad-420a-8e6b-06dc2429d433	2025-06-10	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
Prednisone	PREDNISONE	Advanced Rx of Tennessee, LLC	30956dd5-fe19-d5a9-e063-6394a90a2549	2025-04-04	Warnings, Adverse reactions	Name fallback brand name: Prednisone generic name: PREDNISONE

Application 080209

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#