Application 202179

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	No	No
002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 15MG BASE	No	No
003	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 30MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202179-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10
A202179-002	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10
A202179-003	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202179-002	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202179-003	PREDNISOLONE SODIUM PHOSPHATE	EQ 30MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202179-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	2013-04-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202179-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202179-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202179-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202179-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202179-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202179-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202179-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202179-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202179-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202179-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202179-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202179-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202179-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202179-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202179-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202179-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202179-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202179-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202179-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202179-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202179-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202179-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202179-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202179-003	AB	1	`ea99ee380514…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	ATLANTIC BIOLOGICALS CORP.	96de9cad-2fb7-4947-87ae-4db57563a83a	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
PrednisoLONE Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	d1f937e7-fed5-4079-bd52-5d930b34ae9f	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: PrednisoLONE Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisoLONE sodium phosphate	PREDNISOLONE SODIUM PHOSPHATE	Kesin Pharma	4c0dcbfd-2848-9bd0-e063-6394a90af5a7	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: prednisoLONE sodium phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Chartwell RX, LLC.	2d8c861d-3756-4b75-aaa9-1b82cf11eb94	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	REMEDYREPACK INC.	f87ce1ba-335e-463d-87d5-9af0206f8f61	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Redpharm Drug	3253b63b-0533-6cdc-e063-6294a90aa311	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Edenbridge Pharmaceuticals LLC.	1793e218-7b49-497d-879f-1020de6e6d68	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Chartwell Governmental & Specialty RX, LLC.	5ec401b5-132a-4cd2-8c24-6a5c8b63c2f9	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate Oral Solution	PREDNISOLONE SODIUM PHOSPHATE	BioComp Pharma, Inc.	95208441-1700-5d3f-e053-2a95a90a7da2	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals Inc.	7262fc84-3db2-4475-8ae4-6bec4477cb81	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Atlantic Biologicals Corp	401f7ba6-a4a2-9ae6-e063-6394a90a4210	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Preferred Pharmaceuticals, Inc.	93b372f7-b811-4c15-85c4-c6dbac342cb4	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	a0d74ae0-7b2d-4d36-9211-c76f5063b5a9	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Orapred ODT	PREDNISOLONE SODIUM PHOSPHATE	Advanz Pharma (US) Corp.	1e379543-c4cf-4e72-953b-db15b7f0c2a1	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Amneal Pharmaceuticals NY LLC	286a6032-41de-435a-b6e6-14052b66b85d	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	A-S Medication Solutions	4c507319-8add-4952-8bea-ff77ab17088f	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	acc8badf-d9fd-4f99-a650-a149138b68b1	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	93cd0ddd-1cf5-4064-9a4c-015819c0065a	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Seton Pharmaceuticals, LLC	833ba492-8823-43b4-9a91-8b28d94a740b	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Sodium Phosphate generic name: PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate ODT	PREDNISOLONE SODIUM PHOSPHATE	Ingenus Pharmaceuticals, LLC	ebbc1751-9381-4db1-89ff-ae5a2963fb2c	2024-04-18	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE SODIUM PHOSPHATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4710	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4710	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4715	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4715	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4730	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4730	Prednisolone Sodium Phosphate	prednisolone	Mylan Pharmaceuticals Inc.	ANDA	Current