Application 040401

Type: ANDA
Sponsor: HI TECH PHARMA CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISOLONE	PREDNISOLONE	SYRUP;ORAL	15MG/5ML	No	Yes

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

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
A040401-001	PREDNISOLONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040401-001	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL			2003-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL			2003-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA		2003-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040401-001	PREDNISOLONE	15MG/5ML	SYRUP / ORAL	AA	RS	2003-02-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040401-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040401-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040401-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040401-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040401-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040401-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040401-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040401-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040401-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040401-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040401-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040401-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040401-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040401-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040401-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040401-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040401-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040401-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040401-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040401-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040401-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040401-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040401-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040401-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040401-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040401-001	AA	1	`cb3db0bc1861…`

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone	PREDNISOLONE ORAL	Tulex Pharmaceuticals Inc	757b41c4-a0fe-4a09-8816-a4cdb7558f41	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Prednisolone
Prednisolone	PREDNISOLONE	A-S Medication Solutions	35f0b197-c3ae-445a-8da7-9ffcd4472e05	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Prednisolone generic name: PREDNISOLONE
PREDNISOLONE	PREDNISOLONE	Zhejiang Xianju Pharmaceutical Co., Ltd.	52e6e21d-94b8-41a0-8d13-371c0e66bcee	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE generic name: PREDNISOLONE
Prednisolone	PREDNISOLONE ORAL	Chartwell Governmental & Specialty RX, LLC.	2dac9898-6492-4f34-ad86-83a902e0fe0b	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Prednisolone
Prednisolone	PREDNISOLONE ORAL SOLUTION	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	b079834f-9aa3-4db9-bd53-de28e8f81c04	2025-02-18	Warnings, Adverse reactions	Name fallback brand name: Prednisolone
Prednisolone	PREDNISOLONE	PAI Holdings, LLC dba PAI Pharma	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2024-08-19	Warnings, Adverse reactions	Name fallback brand name: Prednisolone generic name: PREDNISOLONE
PREDNISOLONE	PREDNISOLONE	Hisun Pharmaceuticals USA, Inc.	16d4e064-66d3-4497-8c7d-3aa355f91e1d	2024-08-15	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE generic name: PREDNISOLONE
Prednisolone	PREDNISOLONE	Chartwell RX, LLC	2e965355-f7f2-4dd3-9c5c-1524c6f39c91	2024-06-17	Warnings, Adverse reactions	Name fallback brand name: Prednisolone generic name: PREDNISOLONE
Prednisolone	PREDNISOLONE ORAL	Chartwell RX, LLC	aa40f582-cced-4e6e-90f0-10ab310ab2a7	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Prednisolone
PREDNISOLONE	PREDNISOLONE	Aurobindo Pharma Limited	070f1937-50a5-457f-bef5-4e597014e26d	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE generic name: PREDNISOLONE
PrednisoLONE	PREDNISOLONE	Lannett Company, Inc.	86652e2d-664a-4388-a611-c2a9aa4a4bc8	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: PrednisoLONE generic name: PREDNISOLONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12634-686	Prednisolone	Prednisolone	Apotheca Inc.	ANDA	Current
21695-365	Prednisolone	Prednisolone	Rebel Distributors Corp	ANDA	Current
50090-0655	Prednisolone	Prednisolone	A-S Medication Solutions	ANDA	Current
50090-0655	Prednisolone	Prednisolone	A-S Medication Solutions	ANDA	Current
50090-0655	Prednisolone	Prednisolone	A-S Medication Solutions	ANDA	Current
50090-0655	Prednisolone	Prednisolone	A-S Medication Solutions	ANDA	Current
50383-042	Prednisolone	Prednisolone	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-042	Prednisolone	Prednisolone	Akorn	ANDA	Current
50383-042	Prednisolone	Prednisolone	Akorn	ANDA	Current
50383-042	Prednisolone	Prednisolone	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
53217-193	Prednisolone	Prednisolone	Aidarex Pharmaceuticals LLC	ANDA	Current
61919-291	PREDNISOLONE	PREDNISOLONE	DIRECT RX	ANDA	Current
61919-291	PREDNISOLONE	PREDNISOLONE	DIRECT RX	ANDA	Current
63187-466	Prednisolone	Prednisolone	Proficient Rx LP	ANDA	Current
63187-466	Prednisolone	Prednisolone	Proficient Rx LP	ANDA	Current
63629-1862	Prednisolone	Prednisolone	Bryant Ranch Prepack	ANDA	Current
67296-1656	Prednisolone	Prednisolone	RedPharm Drug, Inc.	ANDA	Current
67296-1656	Prednisolone	Prednisolone	RedPharm Drug, Inc.	ANDA	Current
68258-8987	Prednisolone	Prednisolone	Dispensing Solutions, Inc.	ANDA	Current
68788-9096	Prednisolone	Prednisolone	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9096	Prednisolone	Prednisolone	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9096	Prednisolone	Prednisolone	Preferred Pharmaceuticals, Inc	ANDA	Current
70518-2084	Prednisolone	Prednisolone	REMEDYREPACK INC.	ANDA	Current