Application 200981

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	25MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	No	No
004	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	37.5MG	No	No
005	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200981-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28
A200981-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28
A200981-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28
A200981-004	METOPROLOL TARTRATE	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21
A200981-005	METOPROLOL TARTRATE	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A200981-001	AB
A200981-002	AB
A200981-003	AB
A200981-004	AB
A200981-005	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 6 · 211 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
2026-09-14 22:38:34	2026-08	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 211 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200981-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200981-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200981-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200981-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200981-005	AB	1	`03ed91905a0d…`

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	0ca72c89-82c5-4b31-b515-1a8b8e82ec59	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	621249c4-531b-4138-9bde-77a06ad7816b	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Redpharm Drug	59ed1885-cc00-5325-e063-6294a90a50c2	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	58239cf1-53b4-4ef7-e063-6394a90a65bd	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Proficient Rx LP	4871791a-7679-4345-8fd6-fdb9c9217352	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5476c4fc-ab09-ee1a-e063-6394a90a7a1b	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	a590edb1-3310-49e3-b3d1-dbbb3f81f1c1	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	3bc7d371-6057-a9dc-e063-6394a90a6a9c	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	5fd16fbd-be05-49aa-86a9-0f775c1b5a37	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	9af11192-61fa-44b8-86eb-3a5e68ec1747	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals, Inc.	b4d1e5ba-f1a8-4c77-bd65-db8e9342370b	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e3de73ee-bcc7-ba40-e053-2a95a90a8f8f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	35922e9c-6a4c-446a-8294-a4cd3f3f0d10	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	54754388-39c9-9a02-e063-6394a90a90b3	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5466243e-1e3d-175e-e063-6394a90a5dee	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	fae7a662-9b27-4c5f-80b5-22442f0ae436	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	5987a15b-e86f-4fd7-a377-35a917c0e3fe	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	5371c1af-93fa-39db-e063-6394a90a6111	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e55cd5b5-c739-24ba-e053-2995a90a3ed4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	f7a05d74-f5e9-4236-a967-c57942a2bbf3	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981

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 3 of 3 · 173 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-005	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-006	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-006	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-006	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-006	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-022	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-022	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-023	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-023	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-023	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-023	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-101	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current
72888-101	Metoprolol Tartrate	Metoprolol Tartrate	Advagen Pharma Limited	ANDA	Current