Application 218771

Type: NDA
Sponsor: ALMAJECT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERIPARATIDE	TERIPARATIDE	SOLUTION;SUBCUTANEOUS	0.56MG/2.24ML (0.25MG/ML)	Yes	Yes

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

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
N218771-001	TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N218771-001	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.

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	N218771-001	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218771-001	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218771-001	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218771-001	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218771-001	TERIPARATIDE	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2024-06-04	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218771-001	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2024-06-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218771-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218771-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218771-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218771-001	AP	1	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218771-001	AP	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Teriparatide	TERIPARATIDE	Apotex Corp.	d77d40db-7f38-88eb-fd5d-4282f0642028	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Teriparatide generic name: TERIPARATIDE
Teriparatide	TERIPARATIDE	BluePoint Laboratories	9d3f65e2-e8f0-4d33-b79e-989013dd3ca3	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Teriparatide generic name: TERIPARATIDE
Teriparatide	TERIPARATIDE	Amphastar Pharmaceuticals, Inc.	d38b470a-2e62-487b-b3e7-134d3d1958b5	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Teriparatide generic name: TERIPARATIDE
Teriparatide	TERIPARATIDE	Prasco Laboratories	ab322675-4769-45b0-b146-14fbaa3135d0	2025-06-16	Warnings, Adverse reactions	Name fallback brand name: Teriparatide generic name: TERIPARATIDE
Forteo	TERIPARATIDE	Eli Lilly and Company	aae667c5-381f-4f92-93df-2ed6158d07b0	2025-06-03	Warnings, Adverse reactions	Name fallback generic name: TERIPARATIDE
Bonsity	TERIPARATIDE	Alvogen Inc.	2d0c89a2-3849-adf6-007d-aeca21cf417c	2025-06-01	Warnings, Adverse reactions	Name fallback generic name: TERIPARATIDE
teriparatide	TERIPARATIDE	Alvogen, Inc.	1b007339-dd0d-f019-5e0a-9b1b0f75011c	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: teriparatide generic name: TERIPARATIDE
Teriparatide	TERIPARATIDE	Teva Pharmaceuticals USA, Inc.	d371f0f7-d492-4481-b360-051456d56d65	2024-09-01	Warnings, Adverse reactions	Name fallback brand name: Teriparatide generic name: TERIPARATIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81104	SUPPL	2025-02-06
81103	SUPPL	2025-02-06
81034	SUPPL	2025-02-06
80909	ORIG	2025-02-04
78639	ORIG	2024-07-02
78651	ORIG	2024-06-05
78650	ORIG	2024-06-05