Application 077457

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	No	No
002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	No	No
003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10
A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10
A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077457-001	AP
A077457-002	AP
A077457-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077457-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	2006-02-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077457-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077457-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077457-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077457-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077457-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077457-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077457-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077457-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077457-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077457-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077457-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077457-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077457-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077457-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077457-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077457-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077457-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077457-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077457-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077457-001	AP	1	`8072bd15b7f6…`

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
Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	d6a9a800-889d-417f-b533-1913197d0022	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077457 application number: ANDA077457 ndc (product): 63323-376 ndc (product): 63323-377
Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	f278f0d8-4062-420a-97c3-3a8b88253a08	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077457 application number: ANDA077457 ndc (product): 63323-376 ndc (product): 63323-377

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-365	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-365	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-365	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-365	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-376	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-377	Octreotide	OCTREOTIDE ACETATE	Fresenius Kabi USA, LLC	ANDA	Current