Application 209603

Type: ANDA
Sponsor: TWI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	300MG	No	No
004	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	TABLET;ORAL	400MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209603-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20
A209603-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20
A209603-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20
A209603-004	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2024-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209603-001	AB
A209603-002	AB
A209603-003	AB
A209603-004	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 4 · 136 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	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2024-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A209603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-003	AB	1	`301d65b070ca…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30281c4d-2fd1-167a-e063-6294a90a77c4	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	5101b8dd-6148-465c-9bba-0209ce823fe5	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	d3ca153c-25b2-4506-91bd-bf9d6a4c01fe	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	c0c1a162-cd30-4ac9-bc62-407493ed54a5	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	54b75509-824b-4291-818d-71dc1b88915f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	d5ce687f-4a37-d3e6-e053-2995a90aa974	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603 ndc (product): 51407-614 ndc (product): 51407-615 ndc (product): 51407-616
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	371cb135-6a5f-433d-a87d-ab8521c4aa6d	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	f9af85d3-a5a7-49d6-aff6-1ca2b2d75450	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d4364caf-46c6-4144-9ba5-2c561e4f3a95	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d207396a-068e-4229-88cc-a1a4df7aeff2	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	b4a5f170-a400-4986-8c64-f55d0413f0f6	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Major Pharmaceuticals	35b5fd32-581d-427b-9a13-b7a02846d21d	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Biocon Pharma Inc.	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603 ndc (product): 70377-060 ndc (product): 70377-062 ndc (product): 70377-061
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Northwind Health Company, LLC	faf7a1ff-f18a-8ca7-e053-6394a90a1b1f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	RedPharm Drug	1e1b7355-4802-d277-e063-6394a90aef44	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NuCare Pharmaceuticals , Inc.	3aff731f-1eec-19b5-e063-6294a90a3143	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	30280d40-28df-4c88-93bd-357a7c528906	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-168	Labetalol Hydrochloride	Labetalol Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-169	Labetalol Hydrochloride	Labetalol Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-170	Labetalol Hydrochloride	Labetalol Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
51407-614	Labetalol Hydrochloride	Labetalol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-615	Labetalol Hydrochloride	Labetalol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
51407-616	Labetalol Hydrochloride	Labetalol Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-8898	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8898	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8898	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8899	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8899	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8899	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8900	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8900	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8901	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8901	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8902	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8902	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8903	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8903	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
70377-060	Labetalol Hydrochloride	Labetalol Hydrochloride	Biocon Pharma Inc.	ANDA	Current
70377-061	Labetalol Hydrochloride	Labetalol Hydrochloride	Biocon Pharma Inc.	ANDA	Current
70377-062	Labetalol Hydrochloride	Labetalol Hydrochloride	Biocon Pharma Inc.	ANDA	Current