Application 202353

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.375MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.75MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	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	TE codes	Approval date
A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04
A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04
A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04
A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04
A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202353-001	AB
A202353-002	AB
A202353-003	AB
A202353-004	AB
A202353-005	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 · 220 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
2026-10-15 13:18:30	2026-09	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202353-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202353-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202353-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202353-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202353-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-12-04	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 6 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A202353-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202353-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202353-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202353-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202353-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202353-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202353-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202353-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202353-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A202353-005	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202353-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202353-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202353-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202353-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202353-005	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202353-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202353-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202353-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202353-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202353-005	AB	1	`a50c72e98297…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	29b639e3-25a5-4c2f-b4ea-a119db79fe0c	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	468830df-941c-4363-b432-94de9b7fd2ac	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	46f88017-7b0e-437e-90b1-37bdf9013e72	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	7a5d1b22-179a-44ae-9545-2704414b9905	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	f1ff3695-33db-471d-a3db-89fbb9ed9e0c	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	A-S Medication Solutions	3db0613d-524b-4b33-9a07-602f84d6c304	2026-04-26	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	422b27af-5e7d-4fe1-81bc-ed545c26b476	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	1ebb3e0b-8fd5-4ac8-ba2f-abfcfc0c91ad	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	bd0f7ae1-11ef-4fab-894f-c4c59f75aa99	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	dd4b4e2a-97b5-417d-bb90-bec692dc359b	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Torrent Pharmaceuticals Limited	60167d7c-469f-455a-a113-561841af5e59	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	American Health Packaging	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	f8ac759f-59fb-49e4-a772-4114facdaea3	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Major Pharmaceuticals	978c0e89-35f0-44a2-9302-8bed7e5d60e0	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	44c336d2-01d1-4f13-bad9-549cdc3505ec	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	ScieGen Pharmaceuticals Inc	395fee34-43dc-4840-a6b8-70d5736f9c8b	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Rising Pharma Holdings, Inc.	56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ec	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Bryant Ranch Prepack	794fdab8-1c15-4469-963e-4f9e3495536f	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4fe7106d-4bf6-4794-87cb-8df616994c41	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Pramipexole Dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	b8c94917-73a1-44c2-8fd8-07f45054176b	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Pramipexole dihydrochloride generic name: PRAMIPEXOLE DIHYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.