Application 021318

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTEO	TERIPARATIDE	SOLUTION;SUBCUTANEOUS	0.75MG/3ML (0.25MG/ML)	No	No
002	FORTEO	TERIPARATIDE	SOLUTION;SUBCUTANEOUS	0.6MG/2.4ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021318-001	FORTEO	TERIPARATIDE	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26
N021318-002	FORTEO	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021318-002	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 3 · 82 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	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021318-002	FORTEO	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021318-002	FORTEO	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021318-002	FORTEO	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021318-002	FORTEO	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2008-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	INJECTABLE / SUBCUTANEOUS			2002-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2008-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021318-001	FORTEO	0.75MG/3ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2002-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021318-002	FORTEO	0.6MG/2.4ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-06-25	`782e0a99824c…`

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	N021318-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021318-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021318-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021318-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021318-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021318-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021318-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021318-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021318-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021318-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021318-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021318-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021318-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021318-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021318-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021318-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021318-002	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021318-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021318-001	6977077	2019-08-19	U-597			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-001	7163684	2019-08-19	U-790			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-001	7351414	2019-08-19	U-865			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	6977077	2019-08-19	U-994			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	6977077	2019-08-19	U-982			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	7163684	2019-08-19	U-994			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	7163684	2019-08-19	U-983			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	7351414	2019-08-19	U-994			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	7351414	2019-08-19	U-984			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021318-001	7517334	2025-03-25		Drug product	2014-09-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021318-002	7517334	2025-03-25		Drug product	2014-09-10	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N021318-001	M-302	2023-11-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021318-002	M-302	2023-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021318-001	M-302	2023-11-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021318-002	M-302	2023-11-16	`a72a2bbeb626…`

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
Teriparatide	TERIPARATIDE	Prasco Laboratories	ab322675-4769-45b0-b146-14fbaa3135d0	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021318 application number: NDA021318
Forteo	TERIPARATIDE	Eli Lilly and Company	aae667c5-381f-4f92-93df-2ed6158d07b0	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021318 application number: NDA021318 ndc (product): 0002-8400

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
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current
0002-8400	Forteo	Teriparatide	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79221	SUPPL	2024-07-26
71471	SUPPL	2022-06-28
69647	SUPPL	2021-12-20
69646	SUPPL	2021-12-20
68658	SUPPL	2021-09-20
68563	SUPPL	2021-09-09
66106	SUPPL	2021-02-05
65268	SUPPL	2020-12-01
65261	SUPPL	2020-11-18
62521	SUPPL	2020-04-09
62468	SUPPL	2020-04-07
60231	SUPPL	2019-10-04
60223	SUPPL	2019-10-04
48200	SUPPL	2017-05-02
15178	SUPPL	2013-09-09
5017	SUPPL	2013-09-04
27466	SUPPL	2012-03-15
42097	SUPPL	2011-10-10
5016	SUPPL	2011-08-12
36643	SUPPL	2009-07-23
5013	SUPPL	2009-07-23
5015	SUPPL	2008-06-30
15177	SUPPL	2008-03-05
5014	SUPPL	2008-03-04
27465	SUPPL	2007-05-29
15176	SUPPL	2007-05-29
36642	SUPPL	2004-09-07
27464	SUPPL	2004-09-07
15175	SUPPL	2004-06-07
5012	SUPPL	2004-06-07
21595	ORIG	2004-03-24
23253	ORIG	2003-12-17
27463	ORIG	2001-11-26
15174	ORIG	2001-11-26