Application 089081

Type: ANDA
Sponsor: TEVA

Application Products#

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

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
A089081-001	PRELONE	PREDNISOLONE	15MG/5ML	SOLUTION / ORAL	AA		1986-02-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A089081-001	AA

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089081-001	PRELONE	15MG/5ML	SOLUTION / ORAL	AA	1986-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089081-001	PRELONE	15MG/5ML	SOLUTION / ORAL	AA	1986-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089081-001	PRELONE	15MG/5ML	SOLUTION / ORAL	AA	1986-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089081-001	PRELONE	15MG/5ML	SYRUP / ORAL	AA	1986-02-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089081-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089081-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089081-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089081-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089081-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089081-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089081-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089081-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089081-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089081-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089081-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089081-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089081-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089081-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089081-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089081-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089081-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089081-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089081-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089081-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089081-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089081-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089081-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089081-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089081-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089081-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089081-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089081-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089081-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089081-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089081-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089081-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089081-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089081-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089081-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089081-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089081-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089081-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089081-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089081-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisolone	PREDNISOLONE	A-S Medication Solutions	35f0b197-c3ae-445a-8da7-9ffcd4472e05	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
PREDNISOLONE	PREDNISOLONE	Zhejiang Xianju Pharmaceutical Co., Ltd.	52e6e21d-94b8-41a0-8d13-371c0e66bcee	2026-01-05	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
Prednisolone	PREDNISOLONE	PAI Holdings, LLC dba PAI Pharma	cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3	2024-08-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
PREDNISOLONE	PREDNISOLONE	Hisun Pharmaceuticals USA, Inc.	16d4e064-66d3-4497-8c7d-3aa355f91e1d	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
Prednisolone	PREDNISOLONE	Chartwell RX, LLC	2e965355-f7f2-4dd3-9c5c-1524c6f39c91	2024-06-17	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
PREDNISOLONE	PREDNISOLONE	Aurobindo Pharma Limited	070f1937-50a5-457f-bef5-4e597014e26d	2024-02-16	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE
PrednisoLONE	PREDNISOLONE	Lannett Company, Inc.	86652e2d-664a-4388-a611-c2a9aa4a4bc8	2024-02-14	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-475	Prednisolone	Prednisolone	Aidarex Pharmaceuticals LLC	ANDA	Current
66116-603	Prednisolone	Prednisolone	MedVantx, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43218	ORIG	2003-08-05