Application 072103

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	100MG	No	No
002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A072103-001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20
A072103-002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24
A072103-003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24
A072103-004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24
A072103-005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20
A072103-006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A072103-001	AB
A072103-002	AB
A072103-003	AB
A072103-004	AB
A072103-005	AB
A072103-006	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 4 · 148 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
2026-09-14 22:38:34	2026-08	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-005	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1988-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072103-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1988-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072103-001	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1988-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072103-002	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072103-003	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1988-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072103-004	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1988-05-24	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072103-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072103-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072103-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072103-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072103-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072103-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072103-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072103-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072103-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072103-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A072103-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072103-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072103-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072103-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072103-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072103-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072103-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072103-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072103-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072103-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072103-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072103-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072103-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072103-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-005	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072103-006	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072103-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A072103-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A072103-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A072103-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A072103-005	AB	1	`1c564ffb4f44…`

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 · 8 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 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	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	Actavis Pharma, Inc.	ba02a95d-d82e-4a13-90b4-a219abc0249a	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Desipramine Hydrochloride 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

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
0781-8975	Desipramine Hydrochloride	Desipramine Hydrochloride	Sandoz Inc	ANDA	Current
63629-3990	Desipramine Hydrochloride	Desipramine Hydrochloride	Bryant Ranch Prepack	ANDA	Current