Application 203354

Type: ANDA
Sponsor: DR REDDYS

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 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	TE codes	RLD / RS	Approval date
A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07
A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203354-001	AB
A203354-002	AB
A203354-003	AB
A203354-004	AB
A203354-005	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 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A203354-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203354-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203354-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-005	AB	1	`2680178bc6a6…`

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	Dr. Reddy's Laboratories Limited	00699692-532a-68fd-8a51-3770a81b2208	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203354 application number: ANDA203354 ndc (product): 55111-614 ndc (product): 55111-612 ndc (product): 55111-611 ndc (product): 55111-615 ndc (product): 55111-613

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-611	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-612	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-613	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-614	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-615	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited	ANDA	Current