Application 207322

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	INJECTABLE;INJECTION	EQ 500,000 UNITS BASE/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207322-001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207322-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207322-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207322-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207322-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207322-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207322-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207322-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207322-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207322-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207322-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207322-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207322-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207322-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207322-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207322-001	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A207322-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207322-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207322-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207322-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207322-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207322-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207322-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207322-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207322-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207322-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207322-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207322-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207322-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207322-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207322-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207322-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207322-001	AP	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207322-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polymyxin B	POLYMYXIN B SULFATE	Sagent Pharmaceuticals	7dc505aa-64b0-4b7f-8ee3-2945bde40a34	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322
POLYMYXIN B	POLYMYXIN B SULFATE	FOSUN PHARMA USA INC	fd664927-db58-a1af-e053-6294a90a9048	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322
POLYMYXIN B	POLYMYXIN B SULFATE	Gland Pharma Limited	dc74dee2-1d0b-4fab-a29b-1755fdb5da75	2025-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322 ndc (product): 68083-174

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-596	Polymyxin B	polymyxin B sulfate	Alvogen Inc.	ANDA	Current
47781-596	Polymyxin B	polymyxin B sulfate	Alvogen Inc.	ANDA	Current
51991-939	Polymyxin B	Polymyxin B	Breckenridge Pharmaceutic	ANDA	Current
68083-174	POLYMYXIN B	POLYMYXIN B SULFATE	Gland Pharma Limited	ANDA	Current
68083-174	POLYMYXIN B	POLYMYXIN B SULFATE	Gland Pharma Limited	ANDA	Current
68083-174	POLYMYXIN B	POLYMYXIN B SULFATE	Gland Pharma Limited	ANDA	Current
70860-103	Polymyxin B	polymyxin B sulfate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-103	Polymyxin B	polymyxin B sulfate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-124	Polymyxin B	polymyxin B sulfate	Athenex Pharmaceutical Division, LLC.	ANDA	Current