Application 075215

Type: ANDA
Sponsor: INNOGENIX

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075215-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29
A075215-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29
A075215-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075215-001	AB
A075215-002	AB
A075215-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075215-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075215-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075215-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075215-001	AB	1	`8072bd15b7f6…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	3909ac9e-6818-4c5d-ad0e-52865a574b45	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	35e7bce0-d9ff-4f8b-95c5-218da2a2d929	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	f7f7fade-98a6-4741-bfb9-f1eb54ad4565	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0db22a64-1863-4188-850b-273ea746e327	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	d8b69cc9-bdee-4e24-a3d8-d1887de5a17d	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	6f919513-500e-4a05-935e-b6fc1615368a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 71335-2057
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Innogenix, Inc.	82fc2d64-0572-4a9b-94fc-f6eb8d930c54	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 71247-126 ndc (product): 71247-130 ndc (product): 71247-127
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Method Pharmaceuticals, LLC	733d6e32-ac90-4796-bf25-9d5887c897a5	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 58657-604 ndc (product): 58657-602 ndc (product): 58657-603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0dcd514d-bda8-484b-8cf1-f5656aaab9ce	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	20c26652-52da-4eef-8486-f91eb30e9ff7	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	e2e50571-d8c1-43e7-b90f-877ba1c35c9b	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	5faacbcc-f88f-42f7-8702-791ee82c4d18	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	64cd636d-8b48-4f29-b41d-4a048335793e	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1164
Labetalol Hydrochloride	LABETALOL	Marlex Pharmaceuticals Inc	28c91727-e5a8-48b3-a4df-d7bec8feda40	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 10135-713 ndc (product): 10135-711 ndc (product): 10135-712
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	94abdd54-a8e2-4858-8183-6c5d04dbceb5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1165
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	1fce27dd-90a6-45cf-9bd7-13147d3cc0d7	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1161
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	706a877b-c388-43e7-b083-518111b288b0	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1163
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	5a39bb96-4a60-49e8-859c-16bda0fe18e4	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1166
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	143ae21e-c350-4c92-b318-7537f4e46596	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 63629-1162

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-641	Labetalol	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-642	Labetalol	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-643	Labetalol	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-711	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-711	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-712	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-712	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-713	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
10135-713	Labetalol Hydrochloride	Labetalol	Marlex Pharmaceuticals Inc	ANDA	Current
58657-602	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-602	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-602	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-603	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-603	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-603	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-604	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-604	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-604	Labetalol Hydrochloride	Labetalol Hydrochloride	Method Pharmaceuticals, LLC	ANDA	Current
58657-605	Labetalol Hydrochloride	Labetalol	Method Pharmaceuticals, LLC	ANDA	Current
58657-606	Labetalol Hydrochloride	Labetalol	Method Pharmaceuticals, LLC	ANDA	Current
58657-607	Labetalol Hydrochloride	Labetalol	Method Pharmaceuticals, LLC	ANDA	Current
63629-1161	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1161	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1161	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1162	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1162	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1162	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1163	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1164	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1165	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1166	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1166	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1166	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2450	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9283	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9300	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
69292-501	Labetalol Hydrochloride	Labetalol Hydrochloride	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-502	Labetalol Hydrochloride	Labetalol Hydrochloride	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-503	Labetalol Hydrochloride	Labetalol Hydrochloride	AMICI PHARMACEUTICALS LLC	ANDA	Current
71247-126	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71247-126	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71247-127	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71247-127	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71247-130	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71247-130	Labetalol Hydrochloride	Labetalol Hydrochloride	Innogenix, Inc.	ANDA	Current
71335-2057	Labetalol Hydrochloride	Labetalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30797	ORIG	1999-07-29