Application 206152

Type: ANDA
Sponsor: MICRO LABS

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
A206152-001	PIROXICAM	PIROXICAM	10MG	CAPSULE / ORAL	AB		2017-12-29
A206152-002	PIROXICAM	PIROXICAM	20MG	CAPSULE / ORAL	AB		2017-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206152-001	AB
A206152-002	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	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206152-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	2017-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206152-002	PIROXICAM	20MG	CAPSULE / ORAL	AB	2017-12-29	`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	A206152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206152-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206152-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206152-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206152-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PIROXICAM	PIROXICAM	Bryant Ranch Prepack	8b8eb243-0efb-4777-b627-b7ae042f8823	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206152 application number: ANDA206152 ndc (product): 71335-9622
PIROXICAM	PIROXICAM	Micro Labs Limited	a6335245-7e04-46b9-a505-f47647781e19	2026-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206152 application number: ANDA206152 ndc (product): 42571-177 ndc (product): 42571-176
PIROXICAM	PIROXICAM	Proficient Rx LP	b48a1615-23b5-4db7-bb96-cec551d227f6	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206152 application number: ANDA206152 ndc (product): 71205-203

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-176	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-176	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-176	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-176	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-176	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-177	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-177	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-177	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-177	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
42571-177	PIROXICAM	Piroxicam	Micro Labs Limited	ANDA	Current
50090-4779	PIROXICAM	Piroxicam	A-S Medication Solutions	ANDA	Current
71205-203	PIROXICAM	Piroxicam	Proficient Rx LP	ANDA	Current
71205-203	PIROXICAM	Piroxicam	Proficient Rx LP	ANDA	Current
71205-203	PIROXICAM	Piroxicam	Proficient Rx LP	ANDA	Current
71205-203	PIROXICAM	Piroxicam	Proficient Rx LP	ANDA	Current
71335-9622	PIROXICAM	Piroxicam	Bryant Ranch Prepack	ANDA	Current