Application 080293

Type: ANDA
Sponsor: BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DELTA-DOME	PREDNISONE	TABLET;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080293-001	DELTA-DOME	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080293-001	DELTA-DOME	5MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 11 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	7e541478-4a33-189f-e053-2a91aa0a6962	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	8f7a38c7-7bf9-4951-b529-947cc9a57d6a	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	A-S Medication Solutions	c7c3bb80-73b6-4128-aa5f-0d465a1d84e8	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	cb1b0dc0-6916-4e6f-9775-26ea0f593f83	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Bryant Ranch Prepack	72367ecf-579e-4ef9-8119-54fd46a079b6	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Bryant Ranch Prepack	7601e38d-b7d2-4292-b16e-abff32bb46b3	2024-05-29	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Bryant Ranch Prepack	29c96865-48be-4898-81b7-a6fc9623d3b9	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Proficient Rx LP	94f8ec56-667e-4eda-832d-f2936f12dc36	2024-05-01	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63106192-35d5-6989-e053-2991aa0aa714	2024-04-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	db4a13ff-546d-15b7-e053-2a95a90a6adf	2024-04-23	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2	2024-04-02	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Medsource Pharmaceuticals	131780a0-31f3-6588-e063-6294a90a2f8e	2024-03-07	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE	PREDNISONE	NuCare Pharmaceuticals,Inc.	1289c6d2-2707-baca-e063-6294a90a750d	2024-02-29	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	95cf05e5-1446-43f5-8447-c04877a74781	2024-02-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	ANI Pharmaceuticals, Inc.	7335a293-992b-490c-ab8a-66a7ca1eea30	2024-02-16	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Aurobindo Pharma Limited	7b33767f-a520-4470-8f3f-4e86b38d615a	2024-02-16	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	Aurobindo Pharma Limited	b1ac4c92-e1fd-4015-b172-0932790ae019	2024-02-16	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	NuCare Pharmaceuticals,Inc.	63102d75-9b2b-84a9-e053-2a91aa0a317d	2024-02-09	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	410988ea-456a-454e-932c-fcbdbef04ba9	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	44069d49-4cf4-4f1e-9fbd-b496c6ca81a1	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

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