Application 209785

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No

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

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
A209785-001	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07
A209785-002	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07
A209785-003	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07
A209785-004	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07
A209785-005	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07
A209785-006	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209785-001	AB
A209785-002	AB
A209785-003	AB
A209785-004	AB
A209785-005	AB
A209785-006	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 6 · 204 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	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-005	DESIPRAMINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-006	DESIPRAMINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-001	DESIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-002	DESIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-003	DESIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-004	DESIPRAMINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-07-07	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 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	A209785-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209785-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209785-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209785-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209785-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209785-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209785-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209785-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209785-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209785-004	AB	1	`03ed91905a0d…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	cad14805-64d8-4257-b5f1-d56e0063f0e2	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209785 application number: ANDA209785 ndc (product): 62332-320 ndc (product): 62332-319 ndc (product): 62332-315 ndc (product): 62332-318 ndc (product): 62332-317 ndc (product): 62332-316
DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	8b6d2289-aac9-4007-a73d-c168fd2e1d9e	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209785 application number: ANDA209785 ndc (product): 46708-319 ndc (product): 46708-315 ndc (product): 46708-316 ndc (product): 46708-317 ndc (product): 46708-320 ndc (product): 46708-318

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
46708-315	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-316	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-317	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-318	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-319	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-320	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-315	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-315	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-316	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-316	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-317	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-317	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-318	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-318	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-319	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-319	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-320	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-320	DESIPRAMINE HYDROCHLORIDE	DESIPRAMINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current