Application 009402

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DELESTROGEN	ESTRADIOL VALERATE	INJECTABLE;INJECTION	10MG/ML	Yes	Yes
003	DELESTROGEN	ESTRADIOL VALERATE	INJECTABLE;INJECTION	40MG/ML	Yes	Yes
004	DELESTROGEN	ESTRADIOL VALERATE	INJECTABLE;INJECTION	20MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N009402-002	DELESTROGEN	ESTRADIOL VALERATE	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982
N009402-003	DELESTROGEN	ESTRADIOL VALERATE	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N009402-004	DELESTROGEN	ESTRADIOL VALERATE	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N009402-002	AO
N009402-004	AO

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009402-002	DELESTROGEN	10MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009402-003	DELESTROGEN	40MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009402-004	DELESTROGEN	20MG/ML	INJECTABLE / INJECTION	AO	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N009402-002	AO	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N009402-004	AO	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N009402-002	AO	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009402-004	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009402-002	AO	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009402-004	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009402-002	AO	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009402-004	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-002	AO	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009402-004	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009402-002	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009402-004	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-002	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009402-004	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-002	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009402-004	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-002	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009402-004	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-002	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009402-004	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-002	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-003	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009402-004	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-002	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009402-004	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009402-002	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009402-004	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-002	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-003	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009402-004	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-002	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-003	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009402-004	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-002	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-003	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009402-004	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009402-002	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009402-003	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009402-004	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009402-002	AO	1	`5c6f7cd8ea54…`

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
Delestrogen	ESTRADIOL VALERATE	Par Health USA, LLC	e8f94df9-0692-4462-a7f0-fe019a0a3f07	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 009402 application number: NDA009402 ndc (product): 42023-110 ndc (product): 42023-111

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
42023-110	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current
42023-110	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current
42023-111	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current
42023-111	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current
42023-112	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current
42023-112	Delestrogen	estradiol valerate	Par Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77565	SUPPL	2024-02-20
77542	SUPPL	2024-02-16
70232	SUPPL	2022-02-23
70180	SUPPL	2022-02-17
50306	SUPPL	2017-11-06
50267	SUPPL	2017-11-02
191	SUPPL	2007-10-15
33002	SUPPL	2004-07-28
190	SUPPL	2004-07-28
10728	SUPPL	2004-06-02
33001	SUPPL	2003-12-16
189	SUPPL	2003-12-16
188	SUPPL	2003-12-16