Application 207029

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A207029-001	HYDROCORTISONE	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27
A207029-002	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27
A207029-003	HYDROCORTISONE	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207029-001	AB
A207029-002	AB
A207029-003	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 1 of 4 · 126 observed 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
2026-08-18 06:07:40	2026-07	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-002	HYDROCORTISONE	10MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-003	HYDROCORTISONE	20MG	TABLET / ORAL	AB	2017-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207029-001	HYDROCORTISONE	5MG	TABLET / ORAL	AB	2017-04-27	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207029-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207029-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207029-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207029-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207029-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207029-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207029-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207029-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207029-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207029-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207029-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207029-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207029-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207029-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207029-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207029-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207029-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207029-001	AB	1	`1e350fbaab3a…`

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	Strides Pharma Science Limited	90a46849-5b75-467b-9bc5-8f192d4d20d2	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 64380-972 ndc (product): 64380-970 ndc (product): 64380-971
Hydrocortisone	HYDROCORTISONE	PD-Rx Pharmaceuticals, Inc.	931ed426-89a1-4877-a4a5-cb963d51e717	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 72789-228 ndc (product): 72789-229 ndc (product): 72789-227
Hydrocortisone	HYDROCORTISONE	Strides Pharma Inc.	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 42543-971 ndc (product): 42543-972 ndc (product): 42543-970
Hydrocortisone	HYDROCORTISONE	Chartwell RX, LLC.	4b6edbc4-7afb-4fb5-a16e-66ce70916f09	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029
Hydrocortisone	HYDROCORTISONE	American Health Packaging	506aab0d-9308-4d60-90b3-7d64952fff36	2025-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 60687-582
Hydrocortisone	HYDROCORTISONE	Asclemed USA, Inc.	b8437441-a4a6-4fb5-82eb-e49af69704f4	2021-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207029 application number: ANDA207029 ndc (product): 76420-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42543-140	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-140	Hydrocortisone	Hydrocortisone	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-141	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-141	Hydrocortisone	Hydrocortisone	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-142	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-142	Hydrocortisone	Hydrocortisone	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-970	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-970	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-971	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-971	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-972	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
42543-972	Hydrocortisone	Hydrocortisone	Strides Pharma Inc.	ANDA	Current
60687-511	Hydrocortisone	Hydrocortisone	American Health Packaging	ANDA	Current
60687-511	Hydrocortisone	Hydrocortisone	American Health Packaging	ANDA	Current
60687-582	Hydrocortisone	Hydrocortisone	American Health Packaging	ANDA	Current
63629-8335	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
63629-8335	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
64380-970	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-970	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-970	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-971	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-971	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-971	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-972	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-972	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
64380-972	Hydrocortisone	Hydrocortisone	Strides Pharma Science Limited	ANDA	Current
70934-350	Hydrocortisone	Hydrocortisone	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-350	Hydrocortisone	Hydrocortisone	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-0812	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
71335-0812	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
71335-0812	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
71335-1871	Hydrocortisone	Hydrocortisone	Bryant Ranch Prepack	ANDA	Current
72789-062	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-062	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-062	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-094	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-094	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-094	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-095	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-095	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-095	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-227	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-227	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-228	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-228	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-229	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-229	Hydrocortisone	Hydrocortisone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-031	Hydrocortisone	Hydrocortisone	Asclemed USA, Inc.	ANDA	Current
76420-110	Hydrocortisone	Hydrocortisone	Asclemed USA, Inc.	ANDA	Current