Application 060716

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A060716-001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION		Approved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A060716-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A060716-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A060716-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A060716-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	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
2019-09-15 20:21 UTC	2019-09	A060716-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A060716-001	AP	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polymyxin B	POLYMYXIN B SULFATE	Hikma Pharmaceuticals USA Inc.	18daf0d1-b6f5-46f4-ab2f-01a594f3959c	2022-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060716 application number: ANDA060716 ndc (product): 0143-9941

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9941	Polymyxin B	Polymyxin B sulfate	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18305	SUPPL	2015-03-23
18304	SUPPL	2012-07-30