Application 204205

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	INJECTABLE;INJECTION	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204205-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP		2014-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204205-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204205-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204205-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204205-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204205-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204205-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204205-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204205-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204205-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204205-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204205-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204205-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204205-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204205-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204205-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204205-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204205-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204205-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204205-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204205-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204205-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204205-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204205-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204205-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204205-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204205-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204205-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204205-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204205-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204205-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204205-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204205-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204205-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204205-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204205-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204205-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204205-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204205-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204205-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204205-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204205-001	AP	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	e93d7939-31ad-4fc5-a5f3-6d565cc6d0c1	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 55154-1557
Metoprolol Tartrate	METOPROLOL TARTRATE	FOSUN PHARMA USA INC	1e787808-b3e0-417a-b333-80619d15432b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 72266-122
Metoprolol Tartrate	METOPROLOL TARTRATE	Almaject, Inc.	f0370951-ab26-d4d1-b857-57518f3c4175	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 72611-740
Metoprolol Tartrate	METOPROLOL TARTRATE	Sagent Pharmaceuticals	f3817543-544a-4afa-ac7c-c1b48c1307c2	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Medical Purchasing Solutions, LLC	b632f750-14a0-d27f-e053-2a95a90a1df3	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 71872-7226
Metoprolol Tartrate	METOPROLOL TARTRATE	Medical Purchasing Solutions, LLC	dc667cfc-b344-2ba4-e053-2a95a90a3bb9	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 71872-7283
Metoprolol Tartrate	METOPROLOL TARTRATE	Gland Pharma Limited	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	2020-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205 ndc (product): 68083-131

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-587	Metoprolol Tartrate	metoprolol tartrate	Alvogen Inc.	ANDA	Current
47781-587	Metoprolol Tartrate	metoprolol tartrate	Alvogen Inc.	ANDA	Current
47781-587	Metoprolol Tartrate	metoprolol tartrate	Alvogen Inc.	ANDA	Current
55154-1557	Metoprolol Tartrate	metoprolol tartrate	Cardinal Health 107, LLC	ANDA	Current
55154-1557	Metoprolol Tartrate	metoprolol tartrate	Cardinal Health	ANDA	Current
55154-8427	Metoprolol Tartrate	metoprolol tartrate	Cardinal Health	ANDA	Current
68083-131	Metoprolol Tartrate	Metoprolol Tartrate	Gland Pharma Limited	ANDA	Current
68083-131	Metoprolol Tartrate	Metoprolol Tartrate	Gland Pharma Limited	ANDA	Current
68083-131	Metoprolol Tartrate	Metoprolol Tartrate	Gland Pharma Limited	ANDA	Current
70860-300	Metoprolol Tartrate	metoprolol tartrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-300	Metoprolol Tartrate	metoprolol tartrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-300	Metoprolol Tartrate	metoprolol tartrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71872-7124	Metoprolol Tartrate	metoprolol tartrate	Medical Purchasin Solutions, LLC	ANDA	Current
71872-7124	Metoprolol Tartrate	metoprolol tartrate	Medical Purchasin Solutions, LLC	ANDA	Current
71872-7226	Metoprolol Tartrate	metoprolol tartrate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7283	Metoprolol Tartrate	Metoprolol Tartrate	Medical Purchasing Solutions, LLC	ANDA	Current
72266-122	Metoprolol Tartrate	metoprolol tartrate	Fosun Pharma USA Inc.	ANDA	Current
72266-122	Metoprolol Tartrate	metoprolol tartrate	Fosun Pharma USA Inc.	ANDA	Current
72266-122	Metoprolol Tartrate	Metoprolol Tartrate	FOSUN PHARMA USA INC	ANDA	Current
72266-122	Metoprolol Tartrate	Metoprolol Tartrate	FOSUN PHARMA USA INC	ANDA	Current
72611-740	Metoprolol Tartrate	metoprolol tartrate	Almaject, Inc.	ANDA	Current
72611-740	Metoprolol Tartrate	metoprolol tartrate	Almaject, Inc.	ANDA	Current
72611-740	Metoprolol Tartrate	metoprolol tartrate	Almaject, Inc.	ANDA	Current