Application 076792

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;50MG	No	No
002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	25MG;100MG	No	No
003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	TABLET;ORAL	50MG;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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076792-001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET / ORAL	AB		2004-08-20
A076792-002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET / ORAL	AB		2004-08-20
A076792-003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET / ORAL	AB	RS	2004-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076792-001	AB
A076792-002	AB
A076792-003	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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	A076792-001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;50MG	TABLET / ORAL	AB		2004-08-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076792-002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB		2004-08-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076792-003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	50MG;100MG	TABLET / ORAL	AB		2004-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076792-001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;50MG	TABLET / ORAL	AB		2004-08-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076792-002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB		2004-08-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076792-003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	50MG;100MG	TABLET / ORAL	AB		2004-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076792-001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;50MG	TABLET / ORAL	AB		2004-08-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076792-002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB		2004-08-20	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076792-003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	50MG;100MG	TABLET / ORAL	AB		2004-08-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076792-001	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;50MG	TABLET / ORAL	AB		2004-08-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076792-002	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB		2004-08-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076792-003	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	50MG;100MG	TABLET / ORAL	AB	RS	2004-08-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	A076792-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076792-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076792-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076792-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076792-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076792-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076792-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076792-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076792-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076792-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076792-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076792-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076792-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076792-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076792-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076792-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076792-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076792-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076792-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076792-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076792-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076792-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076792-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076792-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076792-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076792-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076792-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076792-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076792-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076792-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076792-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076792-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076792-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076792-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076792-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076792-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076792-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076792-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076792-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076792-001	AB	1	`79d66fd596c7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	Ajanta Pharma USA Inc.	8b78d7ad-22a8-4a9f-afb5-d18f0a4e6d36	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Metoprolol Tartrate and Hydrochlorothiazide	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	2b77f66f-6891-4977-be8f-7955473d2f92	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate and Hydrochlorothiazide
Metoprolol Tartrate and Hydrochlorothiazide	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	Sun Pharmaceutical Industries, Inc.	faaf13ce-5d8d-4c57-a49f-a7a73daa41a5	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate and Hydrochlorothiazide
Metoprolol Tartrate and Hydrochlorothiazide	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	538ea34a-1ac3-48c8-b841-43be09285e12	2023-01-17	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate and Hydrochlorothiazide

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0424	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0424	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0424	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0424	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0434	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0434	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0434	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0434	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0445	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0445	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0445	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0445	Metoprolol Tartrate and Hydrochlorothiazide	metoprolol tartrate and hydrochlorothiazide	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8962	ORIG	2004-08-25