Application 074217

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074217-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL			1994-05-27
A074217-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL			1994-05-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074217-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	1994-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074217-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	1994-05-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A074217-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074217-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074217-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074217-002	AB	1	`ea99ee380514…`

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 9 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	Proficient Rx LP	a3209878-e763-4a53-9c2b-ad39535f385c	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Proficient Rx LP	c5c8ca26-d3dd-46ba-bf04-6aae9f334445	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Proficient Rx LP	d4c8f068-7410-4543-9a66-7f4c19ff63a5	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ea141b60-b08e-4f0f-9f29-cd765f4d7ca6	2022-03-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Gland Pharma Limited	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	2020-10-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	991b445a-8cdc-4b99-bfd4-7da833f3f5c7	2020-06-04	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	7e9e5e82-10fa-4e9b-b57c-3ec85b05c046	2019-06-11	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5b0286d3-d00e-43cb-9172-efd37801596f	2018-11-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b31ddfe3-bbcd-468a-92a8-1f0ccb3e8879	2018-11-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	b60d2cb0-f2c3-4ad5-8060-5179d5b94256	2018-09-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	97d32bcd-92f7-4c8e-877d-acc355a2350d	2018-07-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-0462	Metoprolol Tartrate	metoprolol tartrate	Actavis Pharma, Inc.	ANDA	Current
0591-0463	Metoprolol Tartrate	metoprolol tartrate	Actavis Pharma, Inc.	ANDA	Current
10544-879	Metoprolol Tartrate	metoprolol tartrate	Blenheim Pharmacal, Inc.	ANDA	Current
33261-545	Metoprolol Tartrate	metoprolol tartrate	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-064	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-064	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-064	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-093	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-093	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-093	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-413	Metoprolol Tartrate	metoprolol tartrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
71335-0996	Metoprolol Tartrate	metoprolol tartrate	Bryant Ranch Prepack	ANDA	Current
71335-0996	Metoprolol Tartrate	metoprolol tartrate	Bryant Ranch Prepack	ANDA	Current
71610-091	Metoprolol Tartrate	metoprolol tartrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current