Application 088832

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	PREDNISONE	10MG	TABLET / ORAL	AB	1985-12-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A088832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088832-001	AB	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Northwind Health Company, LLC	f76db82a-826e-92b0-e053-6294a90a8ec6	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832
Prednisone	PREDNISONE	Mylan Pharmaceuticals Inc.	fec09050-5ac2-451b-a2b9-5a21b2def212	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088832 application number: ANDA088832 ndc (product): 0378-0641

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9739	Prednisone	Prednisone	West-ward Pharmaceuticals Corp	ANDA	Current
0143-9739	Prednisone	Prednisone	West-ward Pharmaceuticals Corp	ANDA	Current
0143-9739	Prednisone	Prednisone	West-ward Pharmaceuticals	ANDA	Current
0378-0641	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0641	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0641	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0641	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0641	Prednisone	Prednisone	Mylan Pharmaceuticals Inc	ANDA	Current
10544-508	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
10544-538	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
21695-306	Prednisone	Prednisone	Rebel Distributors Corp	ANDA	Current
43063-644	Prednisone	Prednisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50436-4325	Prednisone	Prednisone	Unit Dose Services	ANDA	Current
51655-320	Prednisone	Prednisone	Northwind Pharmaceuticals	ANDA	Current
51655-320	Prednisone	Prednisone	Northwind Pharmaceuticals	ANDA	Current
53808-0540	Prednisone	PREDNISONE	State of Florida DOH Central Pharmacy	ANDA	Current
59115-140	Prednisone	Prednisone	Hikma Pharmaceutical	ANDA	Current
61919-404	PREDNISONE	PREDNISONE	Direct Rx	ANDA	Current
61919-404	PREDNISONE	PREDNISONE	Direct Rx	ANDA	Current
64725-1473	Prednisone	Prednisone	TYA Pharmaceuticals	ANDA	Current
67296-1032	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-1032	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
70518-0473	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-0473	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-0473	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-0473	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2115	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2115	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-2115	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
71335-0464	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current
71335-0464	Prednisone	Prednisone	Bryant Ranch Prepack	ANDA	Current