Application 009986

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DELTASONE	PREDNISONE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DELTASONE	PREDNISONE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	DELTASONE	PREDNISONE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	DELTASONE	PREDNISONE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
008	DELTASONE	PREDNISONE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N009986-002	DELTASONE	PREDNISONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009986-005	DELTASONE	PREDNISONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009986-006	DELTASONE	PREDNISONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009986-007	DELTASONE	PREDNISONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009986-008	DELTASONE	PREDNISONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009986-002	DELTASONE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009986-005	DELTASONE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009986-006	DELTASONE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009986-007	DELTASONE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009986-008	DELTASONE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`

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 4 of 12 · 240 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prednisone	PREDNISONE	Sportpharm LLC	5dde7256-d3b8-400d-a0eb-c60078bfc5d9	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Amneal Pharmaceuticals NY LLC	0740ef68-7641-432e-bd46-4710687fc9d7	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	REMEDYREPACK INC.	4bd86b2f-75cb-4711-85e2-b81ed947cb13	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	e9a74862-6a3b-4247-837a-389761b5c352	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	REMEDYREPACK INC.	b540f4af-8f07-4c56-b151-d759440c514a	2026-04-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Bryant Ranch Prepack	70d05ed7-5c4e-4cd1-84cd-0dbe90692c54	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	Northwind Health Company, LLC	fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	3befbdc5-7d20-41b6-ad80-98e1c6b8caf5	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	53c66f70-58fd-4d4c-b054-e5cefdc0c637	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	d6df3295-3118-49af-be05-b1fab0d4adaa	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mg	PREDNISONE	PD-Rx Pharmaceuticals, Inc.	14d50f54-410b-45b2-a639-31498ceaf854	2026-03-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	b5b088b9-8f90-468f-b7a4-a5274aa0aec9	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	DIRECT RX	2a053775-6f6a-455e-b9a8-8b60e6062db3	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	e753e2bc-acca-46eb-888c-ae72fcac6ca4	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	A-S Medication Solutions	a8f6298a-1084-4226-bfd9-a543a26ad2e7	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mg	PREDNISONE	Bryant Ranch Prepack	852ea185-1bda-4c89-a192-ee0f93cba428	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
Prednisone	PREDNISONE	A-S Medication Solutions	71295010-5adb-499b-a03a-5c78b5e79b2d	2026-03-07	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
prednisone	PREDNISONE	Asclemed USA, Inc.	fdcf3271-fae7-47ef-a370-adbdc0a3cf37	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE
PREDNISONE	PREDNISONE	NuCare Pharmaceuticals, Inc.	2760a808-b076-5887-e063-6294a90a79ae	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

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