Application 083677

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISONE	PREDNISONE	TABLET;ORAL	20MG	No	No
002	PREDNISONE	PREDNISONE	TABLET;ORAL	5MG	No	No
003	PREDNISONE	PREDNISONE	TABLET;ORAL	10MG	No	No

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

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	TE codes	RLD / RS	Approval date
A083677-001	PREDNISONE	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982
A083677-002	PREDNISONE	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982
A083677-003	PREDNISONE	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A083677-001	AB
A083677-002	AB
A083677-003	AB

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 2 · 56 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
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083677-001	PREDNISONE	20MG	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083677-002	PREDNISONE	5MG	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083677-003	PREDNISONE	10MG	TABLET / ORAL	AB		1985-12-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A083677-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083677-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A083677-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A083677-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083677-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083677-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083677-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083677-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083677-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083677-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083677-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083677-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083677-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083677-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083677-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083677-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083677-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083677-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083677-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083677-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083677-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083677-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083677-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083677-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083677-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083677-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083677-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083677-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083677-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083677-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083677-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083677-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083677-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083677-001	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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prednisone	PREDNISONE	Golden State Medical Supply, Inc.	1e05e071-0407-0970-e063-6294a90a6c65	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083677 application number: ANDA083677

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9738	Prednisone	Prednisone	West-ward Pharmaceuticals Corp	ANDA	Current
0143-9738	Prednisone	Prednisone	West-ward Pharmaceuticals Corp	ANDA	Current
0143-9738	Prednisone	Prednisone	West-ward Pharmaceuticals	ANDA	Current
0378-0642	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0642	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0642	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0642	Prednisone	Prednisone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0642	Prednisone	Prednisone	Mylan Pharmaceuticals Inc	ANDA	Current
0440-8167	Prednisone	Prednisone	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-473	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
10544-509	Prednisone	Prednisone	Blenheim Pharmacal, Inc.	ANDA	Current
12634-188	Prednisone	Prednisone	Apotheca Inc.	ANDA	Current
21695-307	Prednisone	Prednisone	Rebel Distributors Corp	ANDA	Current
50090-0099	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-0100	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50090-0101	Prednisone	Prednisone	A-S Medication Solutions	ANDA	Current
50436-4326	Prednisone	Prednisone	Unit Dose Services	ANDA	Current
53217-288	Prednisone	Prednisone	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0399	Prednisone	PREDNISONE	State of Florida DOH Central Pharmacy	ANDA	Current
59115-141	Prednisone	Prednisone	Hikma Pharmaceutical	ANDA	Current
61919-342	PREDNISONE	PREDNISONE	DirectRX	ANDA	Current
61919-342	Prednisone	Prednisone	DIRECT RX	ANDA	Current
61919-342	PREDNISONE	PREDNISONE	Direct_Rx	ANDA	Current
61919-342	PREDNISONE	PREDNISONE	Direct_Rx	ANDA	Current
63187-085	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
63187-085	Prednisone	Prednisone	Proficient Rx LP	ANDA	Current
67296-0974	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-0974	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
67296-0974	Prednisone	Prednisone	RedPharm Drug, Inc.	ANDA	Current
68387-240	Prednisone	PREDNISONE	Keltman Pharmaceuticals Inc.	ANDA	Current
68387-241	Prednisone	PREDNISONE	Keltman Pharmaceuticals Inc.	ANDA	Current
69668-120	Deltasone	Prednisone	Oculus Innovative Sciences	ANDA	Current
70518-0205	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-0800	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current
70518-0800	Prednisone	Prednisone	REMEDYREPACK INC.	ANDA	Current