Application 083738

Type: ANDA
Sponsor: BEL MAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	INJECTABLE;INJECTION	25MG/ML	No	No
002	PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	INJECTABLE;INJECTION	50MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083738-001	PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION		Approved before 1982
A083738-002	PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION		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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083738-001	PREDNISOLONE ACETATE	25MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083738-002	PREDNISOLONE ACETATE	50MG/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	Sportpharm LLC	3011a244-24a4-46ef-979a-b5d9e7076246	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Sportpharm LLC	02fc6f0b-d053-49e1-82de-f272dd05d529	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	f0e1b691-73ff-49ee-8a3c-71769b284ab8	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Redpharm Drug	3dd0195c-8522-bbf9-e063-6394a90a9f3e	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PRED MILD	PREDNISOLONE ACETATE	Allergan, Inc.	4fcce64a-94ea-4031-ad5a-c4eddc73a910	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Lupin Pharmaceuticals, Inc.	75fbeab1-ce8d-4999-a875-472174be5cc6	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
prednisolone acetate	PREDNISOLONE ACETATE	Amneal Pharmaceuticals NY LLC	8d8e8f9b-4d65-426f-8c57-451001cdd849	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: prednisolone acetate generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	Sandoz Inc	05d205c7-8f51-46b9-a6c5-4199bc432b26	2024-12-30	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	ab72cf3d-7660-41b1-e053-2995a90a7f44	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Pacific Pharma, Inc.	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	2024-03-19	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE
PRED FORTE	PREDNISOLONE ACETATE	Allergan, Inc.	00a5aa88-e361-4ea7-8922-530c738b726e	2024-02-02	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	A-S Medication Solutions	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	2023-04-30	Warnings, Adverse reactions	Name fallback brand name: Prednisolone Acetate generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Asclemed USA, Inc.	232e40a5-17c5-4cf3-9e3b-110a194ad4be	2021-11-30	Warnings, Adverse reactions	Name fallback brand name: PREDNISOLONE ACETATE generic name: PREDNISOLONE ACETATE

Reported adverse events (FAERS/openFDA)#

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