Application 078894

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.125MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.25MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08
A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08
A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08
A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08
A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08

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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078894-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078894-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078894-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078894-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078894-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2010-10-08	`2680178bc6a6…`

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	A078894-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078894-005	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A078894-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078894-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078894-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078894-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078894-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078894-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078894-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078894-005	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894 ndc (product): 62332-003 ndc (product): 62332-007 ndc (product): 62332-006 ndc (product): 62332-004 ndc (product): 62332-005
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	0a3ed933-ef5b-4091-8ae9-5768ae18514f	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894 ndc (product): 46708-611 ndc (product): 46708-615 ndc (product): 46708-612 ndc (product): 46708-613 ndc (product): 46708-614
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	92f6ef1e-3256-45a7-a409-80dd85e95187	2017-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078894 application number: ANDA078894 ndc (product): 46708-004 ndc (product): 46708-003 ndc (product): 46708-006 ndc (product): 46708-007 ndc (product): 46708-005

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-611	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-612	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-613	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-614	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-615	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current