Application 202147

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COSYNTROPIN	COSYNTROPIN	INJECTABLE;INJECTION	0.25MG/VIAL	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
A202147-001	COSYNTROPIN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP		2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202147-001	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	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202147-001	COSYNTROPIN	0.25MG/VIAL	INJECTABLE / INJECTION	AP	2012-06-29	`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	A202147-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202147-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202147-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202147-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202147-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202147-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202147-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202147-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202147-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202147-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202147-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202147-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202147-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202147-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202147-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202147-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202147-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202147-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202147-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202147-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202147-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202147-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202147-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202147-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202147-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202147-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202147-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202147-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202147-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202147-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202147-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202147-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202147-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202147-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202147-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202147-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202147-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202147-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202147-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202147-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COSYNTROPIN	COSYNTROPIN	HF Acquisition Co LLC, DBA HealthFirst	c6cf2223-4a93-0b28-e053-2a95a90ade53	2024-02-22	Adverse reactions	Exact identifier application applno (ANDA): 202147 application number: ANDA202147 ndc (product): 51662-1567
Cosyntropin	COSYNTROPIN	Sandoz Inc	1342169c-e214-4f22-8363-1fd45b85d1e8	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202147 application number: ANDA202147 ndc (product): 0781-3440
Cosyntropin	COSYNTROPIN	Medical Purchasing Solutions, LLC	09441f78-7350-0cb3-e063-6394a90a46ab	2023-11-03	Adverse reactions	Exact identifier application applno (ANDA): 202147 application number: ANDA202147

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3440	Cosyntropin	Cosyntropin	Sandoz Inc	ANDA	Current
0781-3440	Cosyntropin	Cosyntropin	Sandoz Inc	ANDA	Current
51662-1567	COSYNTROPIN	COSYNTROPIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22874	ORIG	2012-10-09