Application 210347

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIROXICAM	PIROXICAM	CAPSULE;ORAL	10MG	No	No
002	PIROXICAM	PIROXICAM	CAPSULE;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210347-001	PIROXICAM	PIROXICAM	10MG	CAPSULE / ORAL	AB		2018-01-26
A210347-002	PIROXICAM	PIROXICAM	20MG	CAPSULE / ORAL	AB		2018-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210347-001	AB
A210347-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210347-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2018-01-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210347-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2018-01-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210347-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210347-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210347-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210347-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210347-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210347-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210347-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210347-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210347-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210347-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210347-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210347-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210347-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210347-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210347-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210347-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210347-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210347-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210347-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210347-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210347-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210347-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210347-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210347-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210347-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210347-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210347-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210347-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210347-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piroxicam	PIROXICAM	PD-Rx Pharmaceuticals, Inc.	923a81d7-78e7-48e9-901d-e3ce3539aba3	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347 ndc (product): 72789-211 ndc (product): 72789-210
Piroxicam	PIROXICAM	AvKARE	1ea6042e-0090-df18-e063-6394a90a0a0a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347
Piroxicam	PIROXICAM	Strides Pharma Science Limited	6039e036-c0aa-4249-af50-115f49ad758a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347 ndc (product): 64380-843 ndc (product): 64380-842
Piroxicam	PIROXICAM	Direct_Rx	fa56b439-893d-003e-e053-6294a90a865b	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7f5ea9e8-3942-4e84-b237-c38517a97a8e	2023-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210347 application number: ANDA210347 ndc (product): 71335-2067

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-697	Piroxicam	Piroxicam	Quality Care Products, LLC	ANDA	Current
55700-697	Piroxicam	Piroxicam	Quality Care Products, LLC	ANDA	Current
55700-697	Piroxicam	Piroxicam	Quality Care Products, LLC	ANDA	Current
55700-697	Piroxicam	Piroxicam	Quality Care Products, LLC	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Shasun Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-842	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Shasun Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
64380-843	Piroxicam	Piroxicam	Strides Pharma Science Limited	ANDA	Current
71335-2067	Piroxicam	Piroxicam	Bryant Ranch Prepack	ANDA	Current
72789-210	Piroxicam	Piroxicam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-210	Piroxicam	Piroxicam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-211	Piroxicam	Piroxicam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-211	Piroxicam	Piroxicam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current