Application 076313

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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	Yes
002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	No	Yes
003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	No	Yes

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	RLD / RS	Approval date
A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28
A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28
A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	OCTREOTIDE ACETATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076313-001	AP
A076313-002	AP
A076313-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-002	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-003	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076313-001	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2005-03-28	`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	A076313-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076313-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076313-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076313-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076313-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076313-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076313-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076313-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076313-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076313-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076313-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076313-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076313-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076313-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076313-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076313-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076313-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Octreotide Acetate	OCTREOTIDE ACETATE	Hikma Pharmaceuticals USA Inc.	9502860d-0261-4d69-a4be-827a5376d356	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076313 application number: ANDA076313 ndc (product): 0641-6175 ndc (product): 0641-6174 ndc (product): 0641-6176

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6174	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6174	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6174	Octreotide Acetate	Octreotide Acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6174	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6175	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6175	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6175	Octreotide Acetate	Octreotide Acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6175	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6176	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6176	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6176	Octreotide Acetate	Octreotide Acetate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6176	Octreotide Acetate	Octreotide Acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31109	ORIG	2005-03-30