Application 074116

Type: ANDA
Sponsor: NOSTRUM LABS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074116-001	PIROXICAM	10MG	CAPSULE / ORAL	AB	1993-06-15	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074116-001	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074116-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074116-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074116-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074116-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074116-001	AB	1	`ea99ee380514…`

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
Piroxicam	PIROXICAM	Bryant Ranch Prepack	d9684cb2-76f3-4c1b-b9e5-1f8fe55f3695	2024-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074116 application number: ANDA074116
Piroxicam	PIROXICAM	Bryant Ranch Prepack	7ee820e4-a479-4b7d-8730-101ac1f8015c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074116 application number: ANDA074116 ndc (product): 63629-9148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0466	Piroxicam	piroxicam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0466	Piroxicam	piroxicam	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0466	Piroxicam	piroxicam	Mylan Pharmaceuticals Inc.	ANDA	Current
29033-012	Piroxicam	piroxicam	Nostrum Laboratories, Inc.	ANDA	Current
42254-143	Piroxicam	Piroxicam	Rebel Distributors Corp	ANDA	Current
60429-299	Piroxicam	piroxicam	Golden State Medical Supply, Inc.	ANDA	Current
61919-188	piroxicam	piroxicam	DIRECT RX	ANDA	Current
61919-188	piroxicam	piroxicam	DIRECT RX	ANDA	Current
63629-9148	Piroxicam	piroxicam	Bryant Ranch Prepack	ANDA	Current
63629-9148	Piroxicam	piroxicam	Bryant Ranch Prepack	ANDA	Current