Application 019962

Type: NDA
Sponsor: TOPROL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPROL-XL	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG TARTRATE	Yes	Yes
002	TOPROL-XL	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	Yes	No
003	TOPROL-XL	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	Yes	Yes
004	TOPROL-XL	METOPROLOL SUCCINATE	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG TARTRATE	Yes	No

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

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	RLD / RS	Approval date
N019962-001	TOPROL-XL	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-002	TOPROL-XL	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10
N019962-003	TOPROL-XL	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-004	TOPROL-XL	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019962-001	AB
N019962-002	AB
N019962-003	AB
N019962-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	N019962-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019962-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	AB	1	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPROL XL	METOPROLOL SUCCINATE	Melinta Therapeutics, LLC	496ddfaa-7c9c-4888-b747-a210249b367a	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	e236f1ed-b400-4854-81c7-64964422a2f7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962 ndc (product): 71205-162
TOPROL XL	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	a07891a5-152e-4a38-8179-e05a90458a7d	2018-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962 ndc (product): 71610-035

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 2 of 2 · 124 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70347-025	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-050	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-100	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70347-200	TOPROL	Metoprolol succinate	Aralez Pharmaceuticals US Inc.	NDA	Current
70518-0232	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
70518-0234	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
70518-1022	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
70518-1022	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
70518-1258	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
70518-1258	TOPROL	Metoprolol succinate	REMEDYREPACK INC.	NDA	Current
71205-162	METOPROLOL SUCCINATE	Metoprolol succinate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
71205-162	METOPROLOL SUCCINATE	Metoprolol succinate	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
71610-035	TOPROL	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-038	TOPROL	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-373	TOPROL	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-483	METOPROLOL SUCCINATE	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-484	METOPROLOL SUCCINATE	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-496	METOPROLOL SUCCINATE	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-509	METOPROLOL SUCCINATE	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-512	METOPROLOL SUCCINATE	Metoprolol succinate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73748	SUPPL	2023-03-14
73747	SUPPL	2023-03-14
73746	SUPPL	2023-03-14
73745	SUPPL	2023-03-14
71222	SUPPL	2022-06-07
71201	SUPPL	2022-06-02
69871	SUPPL	2022-01-13
69866	SUPPL	2022-01-13
34159	SUPPL	2014-05-12
19908	SUPPL	2014-05-08
1868	SUPPL	2012-11-05
34158	SUPPL	2012-11-02
12108	SUPPL	2010-03-26
19906	SUPPL	2010-03-24
19907	SUPPL	2010-01-26
12109	SUPPL	2010-01-20
34157	SUPPL	2009-03-02
1867	SUPPL	2009-03-02
12107	SUPPL	2008-02-25
19905	SUPPL	2008-02-19
34156	SUPPL	2007-07-24
1866	SUPPL	2007-07-24
19904	SUPPL	2007-03-23
34155	SUPPL	2006-08-04
19903	SUPPL	2006-08-04
19902	SUPPL	2006-05-05
41109	SUPPL	2005-07-15
41108	SUPPL	2005-07-15
20435	SUPPL	2005-07-15
20434	SUPPL	2005-07-15
19901	SUPPL	2005-04-12
34154	SUPPL	2005-02-17
1865	SUPPL	2005-02-17
1864	SUPPL	2003-01-30
41111	SUPPL	2002-05-30
19900	SUPPL	2002-03-05
41110	SUPPL	2000-07-20
19899	SUPPL	2000-07-10
12106	SUPPL	2000-07-10
52041	SUPPL	1900-01-01
52039	SUPPL	1900-01-01
52038	SUPPL	1900-01-01
52037	SUPPL	1900-01-01