Application 081271

Type: ANDA
Sponsor: MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TEXACORT	HYDROCORTISONE	SOLUTION;TOPICAL	2.5%	No	Yes

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
A081271-001	TEXACORT	HYDROCORTISONE	2.5%	SOLUTION / TOPICAL		RS	1992-04-17

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081271-001	TEXACORT	2.5%	SOLUTION / TOPICAL	RS	1992-04-17	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Texacort	HYDROCORTISONE	Mission Pharmacal Company	25279d46-6bad-471f-8bd6-736d53cfd942	2026-01-08	Adverse reactions	Exact identifier application applno (ANDA): 081271 application number: ANDA081271 ndc (product): 0178-0455
Hydrocortisone	HYDROCORTISONE	Trifluent Pharma LLC	20508a94-01bc-4f1d-a42b-122a31402aaf	2025-12-01	Adverse reactions	Exact identifier application applno (ANDA): 081271 application number: ANDA081271

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-0455	Texacort	Hydrocortisone	Mission Pharmacal Company	ANDA	Current
0178-0455	Texacort	Hydrocortisone	Mission Pharmacal Company	ANDA	Current
0178-0455	Texacort	Hydrocortisone	Mission Pharmacal Company	ANDA	Current
0178-0455	Texacort	Hydrocortisone	Mission Pharmacal Company	ANDA	Current