Application 209256

Type: ANDA
Sponsor: HIKMA PHARMS

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
A209256-001	PIROXICAM	PIROXICAM	10MG	CAPSULE / ORAL			2017-08-11
A209256-002	PIROXICAM	PIROXICAM	20MG	CAPSULE / ORAL			2017-08-11

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	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL		2017-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL		2017-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209256-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-08-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209256-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-08-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209256-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209256-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209256-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209256-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209256-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209256-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209256-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209256-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209256-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209256-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209256-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209256-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209256-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209256-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209256-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209256-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209256-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209256-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209256-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209256-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209256-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209256-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209256-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209256-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209256-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209256-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A209256-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209256-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209256-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209256-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209256-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209256-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209256-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209256-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209256-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209256-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209256-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209256-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209256-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209256-002	AB	1	`3bdfa0b2c4d7…`

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 · 17 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	Name fallback brand name: Piroxicam generic name: PIROXICAM
PIROXICAM	PIROXICAM	Bryant Ranch Prepack	8b8eb243-0efb-4777-b627-b7ae042f8823	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIROXICAM generic name: PIROXICAM
PIROXICAM	PIROXICAM	Micro Labs Limited	a6335245-7e04-46b9-a505-f47647781e19	2026-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIROXICAM generic name: PIROXICAM
Piroxicam	PIROXICAM	Unichem Pharmaceuticals (USA), Inc.	69631088-2645-4cc9-9c64-a36111ab5d21	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	AvKARE	1ea6042e-0090-df18-e063-6394a90a0a0a	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Strides Pharma Science Limited	6039e036-c0aa-4249-af50-115f49ad758a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Teva Pharmaceuticals USA, Inc.	f1123fe1-b79c-430b-8548-08cd6e518482	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Direct_Rx	fa56b439-893d-003e-e053-6294a90a865b	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	99351f77-46b8-4741-9193-1a6d6a7b0b18	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	d9684cb2-76f3-4c1b-b9e5-1f8fe55f3695	2024-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	1cd10ca2-f0a5-4b3a-bc5f-e25aba1f903c	2024-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7ee820e4-a479-4b7d-8730-101ac1f8015c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7f5ea9e8-3942-4e84-b237-c38517a97a8e	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	bf53d94d-9808-44c0-a01b-a08975bc6e21	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
Piroxicam	PIROXICAM	Bryant Ranch Prepack	0373da3a-7779-4e26-87f1-cd346018282c	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM
PIROXICAM	PIROXICAM	Proficient Rx LP	b48a1615-23b5-4db7-bb96-cec551d227f6	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PIROXICAM generic name: PIROXICAM
Piroxicam	PIROXICAM	Proficient Rx LP	23972bf0-e5b8-4f4b-97d0-caa05d6b061c	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Piroxicam generic name: PIROXICAM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-3107	Piroxicam	Piroxicam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-3107	Piroxicam	Piroxicam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-3107	Piroxicam	Piroxicam	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-3108	Piroxicam	Piroxicam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-3108	Piroxicam	Piroxicam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-3108	Piroxicam	Piroxicam	West-Ward Pharmaceuticals Corp	ANDA	Current