Application 090527

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090527-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29
A090527-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29
A090527-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29
A090527-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090527-001	AA
A090527-002	AA
A090527-003	AA
A090527-004	AA

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 5 · 176 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	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A090527-001	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-002	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-003	AA	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-004	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090527-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-003	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-004	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090527-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090527-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	AA	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 3 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2df51a19-a39a-0ec8-e063-6394a90a147c	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	775e99c4-e18d-4648-a0e3-8709950249ff	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	94530e4d-b1c0-6171-e053-2a95a90a05fa	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	7ae650f7-a481-4637-a9a2-9bda43a5a288	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a862321d-ebc1-7676-e053-2995a90a5861	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ff2c4d1e-33ee-40d7-955b-d736f0559f39	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	10f3e76e-9bba-4151-89fb-90d823a0a68c	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Health Packaging	2e82655e-8435-46fa-b734-8e7c6e803453	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	f9f56326-6d72-47d3-89ac-3625b8a6d713	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f07abdec-6d94-45b6-be1b-10a898ea28c2	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	8ade1ffe-3738-4aa1-b9c7-59f7290600b9	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b61d1b0-c699-67a8-e054-00144ff88e88	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4b7d3378-86f8-0a5f-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	a456bc34-0c79-44f4-9119-50028a978f5f	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Civica, Inc.	ffa483a4-de2a-4d42-ad27-afacd37f28e4	2024-04-28	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE hydrochloride	HYDRALAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	3f5f1204-d289-40e9-be84-a29352f64bfb	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c2638ae6-a210-490f-8389-bbed6a3229c5	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	8224aa3d-b1b9-40df-93fd-a91c6a158898	2024-02-20	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-944	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0138	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2423	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0882	Hydralazine Hydrochloride	Hydralazine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
68462-341	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-342	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-343	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-344	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current