Application 202164

Type: ANDA
Sponsor: MACLEODS 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 44.

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
A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20
A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20
A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20
A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20
A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20

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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202164-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	2012-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202164-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	2012-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202164-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	2012-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202164-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	2012-09-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202164-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	2012-09-20	`1e350fbaab3a…`

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	A202164-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202164-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A202164-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202164-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202164-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202164-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202164-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202164-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202164 application number: ANDA202164 ndc (product): 33342-034 ndc (product): 33342-032 ndc (product): 33342-035 ndc (product): 33342-033 ndc (product): 33342-031

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-031	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-031	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-032	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-032	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-033	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-033	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-034	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-034	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-035	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-035	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
50090-2676	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3350	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3350	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
63629-8105	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1112	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1185	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1185	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1196	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1196	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current