Application 080157

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRAZINAMIDE	PYRAZINAMIDE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080157-001	PYRAZINAMIDE	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080157-001	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080157-001	PYRAZINAMIDE	500MG	TABLET / ORAL	AB	RLD, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080157-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080157-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080157-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080157-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080157-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080157-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080157-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080157-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080157-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080157-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080157-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080157-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080157-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080157-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080157-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080157-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080157-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080157-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080157-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080157-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080157-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080157-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A080157-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080157-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080157-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080157-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080157-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080157-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080157-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080157-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080157-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080157-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080157-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080157-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080157-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080157-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080157-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080157-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080157-001	AB	1	`a50c72e98297…`

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
Pyrazinamide	PYRAZINAMIDE	ANI Pharmaceuticals, Inc.	262d8829-728c-48db-b89b-88d13b87e684	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157 ndc (product): 70954-484
PYRAZINAMIDE	PYRAZINAMIDE TABLET	MARLEX PHARMACEUTICALS, INC	db250a85-2e20-87e9-e053-2a95a90a72b6	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157 ndc (product): 10135-735
Pyrazinamide	PYRAZINAMIDE	American Health Packaging	e2dbbdf9-ddfd-4d6d-ad42-6e658969f11e	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080157 application number: ANDA080157

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6696	Pyrazinamide	Pyrazinamide	Major Pharmaceuticals	ANDA	Current
0904-6696	Pyrazinamide	Pyrazinamide	Major Pharmaceuticals	ANDA	Current
0904-6696	Pyrazinamide	Pyrazinamide	Major Pharmaceuticals	ANDA	Current
10135-735	PYRAZINAMIDE	pyrazinamide tablet	MARLEX PHARMACEUTICALS, INC	ANDA	Current
50090-0521	Pyrazinamide	Pyrazinamide	A-S Medication Solutions	ANDA	Current
50090-0521	Pyrazinamide	Pyrazinamide	A-S Medication Solutions	ANDA	Current
50090-5963	Pyrazinamide	Pyrazinamide	A-S Medication Solutions	ANDA	Current
60687-138	Pyrazinamide	Pyrazinamide	American Health Packaging	ANDA	Current
60687-138	Pyrazinamide	Pyrazinamide	American Health Packaging	ANDA	Current
60687-138	Pyrazinamide	Pyrazinamide	American Health Packaging	ANDA	Current
67253-660	Pyrazinamide	Pyrazinamide	DAVA Pharmaceuticals, Inc.	ANDA	Current
67253-660	Pyrazinamide	Pyrazinamide	Par Pharmaceutical	ANDA	Current
70518-0085	Pyrazinamide	Pyrazinamide	REMEDYREPACK INC.	ANDA	Current
70518-0085	Pyrazinamide	Pyrazinamide	REMEDYREPACK INC.	ANDA	Current
70518-0085	Pyrazinamide	Pyrazinamide	REMEDYREPACK INC.	ANDA	Current
70518-0085	Pyrazinamide	Pyrazinamide	REMEDYREPACK INC.	ANDA	Current
70954-484	Pyrazinamide	Pyrazinamide	Novitium Pharma LLC	ANDA	Current