Application 200653

Type: ANDA
Sponsor: MYLAN

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 43.

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
A200653-001	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL			2014-06-27
A200653-002	DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL			2014-06-27

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 2 of 3 · 86 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
2022-03-09 01:35 UTC	2022-03	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2014-06-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2014-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2014-06-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2014-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	2014-06-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	2014-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200653-001	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL		2014-06-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A200653-002	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL		2014-06-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A200653-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200653-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A200653-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200653-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200653-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200653-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200653-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200653-002	AB	1	`ea99ee380514…`

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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	KVK-TECH, INC.	9fba5e90-f541-4588-a5e9-b56198f17e87	2024-02-21	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Fresenius Kabi USA, LLC	9725ba8e-ac0f-4655-bb98-9ea926142815	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Fresenius Kabi USA, LLC	0d96944d-736d-4b56-b726-d21eacd8bc85	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	BluePoint Laboratories	c04357fd-478a-4909-b098-ae6710be071c	2023-08-04	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries Limited	539d7da2-72b8-45f9-836c-4e3351dd488e	2023-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries Limited	cdec2cc2-4fd9-474e-884f-d0599e40948f	2023-04-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Gland Pharma Limited	848d5173-ce26-46bf-b180-7ed13f0233b5	2023-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Gland Pharma Limited	7f4e5a22-85e8-4c28-9ebf-d6ebc75ad653	2022-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sagent Pharmaceuticals	40752c75-d09b-4013-9024-442048145b63	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: desmopressin acetate generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sagent Pharmaceuticals	39381e84-0e87-4731-b725-f0fdf4b5ca2b	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: desmopressin acetate generic name: DESMOPRESSIN ACETATE
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	651f6fee-a2c7-431b-8d5d-58b156c72244	2022-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries, Inc.	9fd48eec-aa24-4888-b99f-d409ada958a7	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Dr. Reddy's Laboratories Inc.	60dd8694-58d8-d88e-26f2-f28baa53787e	2022-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	e87b6cfd-5677-4398-883d-7ced5dd678ef	2022-03-30	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bauch & Lomb Incorporated	8ca799f1-7029-4527-9ab4-7512504bb8e2	2021-09-01	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	6d55baa9-2b62-469c-93ae-3909ab249332	2021-02-03	Warnings, Adverse reactions	Name fallback generic name: DESMOPRESSIN ACETATE
desmopressin acetate	DESMOPRESSIN ACETATE	Sun Pharmaceutical Industries, Inc.	2dc2cec8-6953-4a33-9356-11534fba1fb8	2020-01-23	Warnings, Adverse reactions	Name fallback brand name: desmopressin acetate generic name: DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Dr.Reddys' Laboratories Inc	15179e0c-f677-307f-d1e1-5910de4c212f	2019-11-30	Warnings, Adverse reactions	Name fallback brand name: DESMOPRESSIN ACETATE generic name: DESMOPRESSIN ACETATE
Desmopressin Acetate	DESMOPRESSIN ACETATE	Glenmark Pharmaceuticals Inc.,USA	7a26b415-77cd-4b2f-9c76-fa52d2eb6be6	2019-06-28	Warnings, Adverse reactions	Name fallback brand name: Desmopressin Acetate generic name: DESMOPRESSIN ACETATE

Reported adverse events (FAERS/openFDA)#

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