Application 072101

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072101-001	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072101-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072101-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072101-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072101-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072101-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072101-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072101-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072101-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072101-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072101-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072101-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072101-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072101-001	AB	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072101-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072101-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072101-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072101-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072101-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072101-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072101-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072101-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072101-001	AB	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	dc1601be-e16a-411f-b9b8-01c51abb2441	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESIPRAMINE HYDROCHLORIDE generic name: DESIPRAMINE HYDROCHLORIDE
Desipramine Hydrochloride	DESIPRAMINE	Amneal Pharmaceuticals NY LLC	a3b4b25d-0ddb-4531-badb-f1ba3168ac07	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desipramine Hydrochloride
Desipramine Hydrochloride	DESIPRAMINE HYDROCHLORIDE	Chartwell RX, LLC	6ab5e113-82ef-493d-a4e3-a2756608fa60	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desipramine Hydrochloride generic name: DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ee14dd2c-c54b-4cd1-a3a0-f7ad5a5a0ed0	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESIPRAMINE HYDROCHLORIDE generic name: DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	7280f157-3fff-41c5-b3f4-510b8bacdaba	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESIPRAMINE HYDROCHLORIDE generic name: DESIPRAMINE HYDROCHLORIDE
Desipramine Hydrochloride	DESIPRAMINE HYDROCHLORIDE	Actavis Pharma, Inc.	ba02a95d-d82e-4a13-90b4-a219abc0249a	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desipramine Hydrochloride generic name: DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	cad14805-64d8-4257-b5f1-d56e0063f0e2	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESIPRAMINE HYDROCHLORIDE generic name: DESIPRAMINE HYDROCHLORIDE
Norpramin	DESIPRAMINE HYDROCHLORIDE	Validus Pharmaceuticals LLC	70b562ea-9f21-4e4a-b3ed-0590b2892f6a	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	8b6d2289-aac9-4007-a73d-c168fd2e1d9e	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DESIPRAMINE HYDROCHLORIDE generic name: DESIPRAMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8973	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
68788-7750	Desipramine Hydrochloride	Desipramine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7750	Desipramine Hydrochloride	Desipramine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7750	Desipramine Hydrochloride	Desipramine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current