Application 204518

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, 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	2.25MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3.75MG	No	No
007	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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02
A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A204518-001	AB
A204518-002	AB
A204518-003	AB
A204518-004	AB
A204518-005	AB
A204518-006	AB
A204518-007	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 8 · 294 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	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-006	PRAMIPEXOLE DIHYDROCHLORIDE	3.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-007	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-004	PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-005	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-01-02	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 245 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	A204518-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204518-007	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204518-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204518-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204518-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204518-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204518-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204518-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204518-005	AB	1	`b8a1b40f171c…`

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
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Inc.	e18b67b6-a085-43e5-bb2b-fe74fa00cb65	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204518 application number: ANDA204518 ndc (product): 62332-156 ndc (product): 62332-157 ndc (product): 62332-160 ndc (product): 62332-155 ndc (product): 62332-159 ndc (product): 62332-154 ndc (product): 62332-158
Pramipexole Dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Alembic Pharmaceuticals Limited	b6935240-ee81-49ef-adad-fb900d7f5127	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204518 application number: ANDA204518 ndc (product): 46708-576 ndc (product): 46708-575 ndc (product): 46708-578 ndc (product): 46708-574 ndc (product): 46708-579 ndc (product): 46708-580 ndc (product): 46708-577

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-574	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-575	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-576	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-577	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-578	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-579	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-580	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current