Application 091486

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXACILLIN SODIUM	OXACILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
002	OXACILLIN SODIUM	OXACILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091486-001	OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2014-08-25
A091486-002	OXACILLIN SODIUM	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091486-002	AP

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 · 84 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
2026-08-18 06:07:40	2026-07	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091486-001	OXACILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091486-002	OXACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		2014-08-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091486-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091486-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091486-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091486-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091486-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091486-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091486-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091486-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091486-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091486-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091486-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091486-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091486-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091486-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091486-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091486-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091486-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091486-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091486-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091486-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091486-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091486-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091486-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091486-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091486-002	AP	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A091486-002	AP	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxacillin	OXACILLIN	Onesource Specialty Pharma Limited	4972ec74-1d9a-de9b-e063-6394a90af786	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091486 application number: ANDA091486
Oxacillin	OXACILLIN	Armas Pharmaceuticals Inc.	8e99d6fe-42ab-44c1-8b51-e4ac7406dbe4	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091486 application number: ANDA091486 ndc (product): 72485-409

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72485-409	Oxacillin	Oxacillin	Armas Pharmaceuticals Inc.	ANDA	Current
82449-506	oxacillin	oxacillin	Steriscience Specialties Private Limited	ANDA	Current
82449-506	oxacillin	oxacillin	Steriscience Specialties Private Limited	ANDA	Current
82449-506	oxacillin	oxacillin	Steriscience Specialties Private Limited	ANDA	Current