Application 019955

Type: NDA
Sponsor: FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DDAVP	DESMOPRESSIN ACETATE	TABLET;ORAL	0.1MG	Yes	No
002	DDAVP	DESMOPRESSIN ACETATE	TABLET;ORAL	0.2MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019955-001	DDAVP	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06
N019955-002	DDAVP	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019955-001	AB
N019955-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N019955-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019955-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019955-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019955-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019955-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019955-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019955-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019955-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019955-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019955-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019955-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019955-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019955-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019955-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019955-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019955-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019955-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019955-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	52133714-37d1-458d-9839-f0bd206711ea	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	c01048e8-d28f-4085-9c37-3d5d48395a77	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955 ndc (product): 69918-101 ndc (product): 69918-201
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	6d55baa9-2b62-469c-93ae-3909ab249332	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955 ndc (product): 55566-2700 ndc (product): 55566-2600

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55566-2600	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2600	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2600	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2600	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2700	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2700	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2700	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
55566-2700	DDAVP	Desmopressin Acetate	Ferring Pharmaceuticals Inc.	NDA	Current
69918-101	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-101	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-101	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-101	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-101	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-201	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-201	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-201	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-201	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current
69918-201	Desmopressin Acetate	Desmopressin Acetate	Amring Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70437	SUPPL	2022-03-08
23563	ORIG	2007-12-04
19892	SUPPL	2007-11-08
34143	SUPPL	2007-11-07
19891	SUPPL	2005-11-17
12098	SUPPL	2005-11-16
19890	SUPPL	2003-11-25