Application 050095

Type: NDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPASTAT SULFATE	CAPREOMYCIN SULFATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes

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
N050095-001	CAPASTAT SULFATE	CAPREOMYCIN SULFATE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982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	N050095-001	CAPASTAT SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050095-001	CAPASTAT SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050095-001	CAPASTAT SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050095-001	CAPASTAT SULFATE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a50c72e98297…`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
2019-12-13 00:20 UTC	2019-12	N050095-001	AP	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	N050095-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050095-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050095-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050095-001	AP	1	`ea99ee380514…`

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current
17478-080	CAPASTAT SULFATE	Capreomycin	Akorn	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73240	SUPPL	2023-01-18
73238	SUPPL	2023-01-18
60196	SUPPL	2019-10-02
57304	SUPPL	2019-01-22
57236	SUPPL	2019-01-17
17798	SUPPL	2008-07-29
29978	SUPPL	2008-07-25
38912	SUPPL	2003-06-22
7691	SUPPL	2003-06-22