Application 217193

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LANREOTIDE ACETATE	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	No	No
002	LANREOTIDE ACETATE	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	No	No
003	LANREOTIDE ACETATE	LANREOTIDE ACETATE	SOLUTION;SUBCUTANEOUS	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	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
A217193-001	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21
A217193-002	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21
A217193-003	LANREOTIDE ACETATE	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217193-001	AB
A217193-002	AB
A217193-003	AB

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 · 42 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	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-002	LANREOTIDE ACETATE	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-003	LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217193-001	LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)	SOLUTION / SUBCUTANEOUS	AB	2024-05-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A217193-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217193-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217193-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217193-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217193-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217193-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217193-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217193-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217193-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217193-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217193-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217193-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217193-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217193-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217193-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217193-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217193-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217193-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217193-003	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217193-001	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANREOTIDE ACETATE	LANREOTIDE ACETATE	EXELAN PHARMACEUTICALS, INC.	eec3c37e-83a7-4195-bccf-cd5973459eef	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217193 application number: ANDA217193
LANREOTIDE ACETATE	LANREOTIDE ACETATE	Cipla USA Inc.	2892b4c3-0329-4d29-97ff-3b45283bbab1	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217193 application number: ANDA217193

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78843	ORIG	2024-06-20