Application 077414

Type: ANDA
Sponsor: APOTEX INC

Application Products#

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

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
A077414-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB		2006-03-07
A077414-002	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB		2006-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077414-001	AB
A077414-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077414-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2006-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077414-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2006-03-07	`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	A077414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077414-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077414-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077414-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077414-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077414-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077414-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077414-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077414-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077414-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077414-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077414-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077414-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077414-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077414-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077414-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077414-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077414-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077414-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077414-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077414-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077414-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077414-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077414-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077414-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077414-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077414-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077414-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077414-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077414-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	American Health Packaging	0d447b48-3f4b-430e-9e68-d8b9401c002e	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077414 application number: ANDA077414
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	dc9b0dad-d265-4dff-8191-d936280d85a2	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077414 application number: ANDA077414
Desmopressin Acetate	DESMOPRESSIN ACETATE	Apotex Corp.	72aeef35-c102-b628-0219-9822651887eb	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077414 application number: ANDA077414 ndc (product): 60505-0257 ndc (product): 60505-0258
Desmopressin Acetate	DESMOPRESSIN ACETATE	BluePoint Laboratories	c04357fd-478a-4909-b098-ae6710be071c	2023-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077414 application number: ANDA077414

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0257	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
60505-0257	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
60505-0257	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
60505-0258	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
60505-0258	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
60505-0258	Desmopressin Acetate	desmopressin acetate	Apotex Corp.	ANDA	Current
70518-3148	Desmopressin Acetate	desmopressin acetate	REMEDYREPACK INC.	ANDA	Current
70518-3149	Desmopressin Acetate	desmopressin acetate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52730	SUPPL	2018-02-27