Application 089074

Type: ANDA
Sponsor: PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STIE-CORT	HYDROCORTISONE	LOTION;TOPICAL	2.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089074-001	STIE-CORT	HYDROCORTISONE	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089074-001	AT

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 · 43 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
2026-09-14 22:38:34	2026-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL		RS	1985-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL		RS	1985-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT		1985-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089074-001	STIE-CORT	2.5%	LOTION / TOPICAL	AT	RS	1985-11-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A089074-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089074-001	AT	1	`caaa826d4ba7…`
2025-08-23 18:47 UTC	2025-08	A089074-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089074-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089074-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089074-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089074-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089074-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089074-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089074-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089074-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089074-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089074-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089074-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089074-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089074-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089074-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089074-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089074-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089074-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089074-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089074-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089074-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089074-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089074-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089074-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089074-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089074-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089074-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089074-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089074-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089074-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089074-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089074-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089074-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089074-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089074-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089074-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089074-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089074-001	AT	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	8c03671d-28ab-4027-8f5f-d342177ce5f2	2025-10-28	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0d85f349-2dc7-44a5-b5bd-83ac78d44d1d	2025-09-24	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	0cb39a3d-4d3b-4820-b3bd-eff642e08a41	2025-01-28	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074 ndc (product): 63629-8668
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	e64cae82-fd7b-47c8-ada9-4dcb283f1d1f	2024-08-07	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074 ndc (product): 63629-9416
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	a2c18606-631f-4e89-8936-3d635a41c37d	2024-04-03	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074 ndc (product): 63629-2529
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	f05b7fa6-26a9-4aca-8975-819ece891060	2023-12-31	Adverse reactions	Exact identifier application applno (ANDA): 089074 application number: ANDA089074 ndc (product): 45802-937

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-937	hydrocortisone	hydrocortisone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-937	hydrocortisone	hydrocortisone	Perrigo New York Inc	ANDA	Current
63629-2529	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-2529	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-2529	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8668	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8668	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8668	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-9416	hydrocortisone	hydrocortisone	Bryant Ranch Prepack	ANDA	Current