Application 210979

Type: ANDA
Sponsor: FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/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
A210979-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210979-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2018-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2018-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2018-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2018-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION			2018-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210979-001	DICYCLOMINE HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210979-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210979-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210979-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210979-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210979-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210979-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210979-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210979-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210979-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210979-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210979-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210979-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210979-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210979-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210979-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210979-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210979-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210979-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210979-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210979-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210979-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210979-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210979-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210979-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210979-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210979-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210979-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210979-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210979-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210979-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210979-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210979-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210979-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210979-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210979-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210979-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210979-001	AP	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	Fosun Pharma USA Inc.	cbc22f25-e100-4c59-8f38-5f82113166fb	2019-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210979 application number: ANDA210979 ndc (product): 72266-127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-320	DICYCLOMINE HYDROCHLORIDE	Dicyclomine Hydrochloride	Gland Pharma Limited	ANDA	Current
72266-127	DICYCLOMINE HYDROCHLORIDE	Dicyclomine Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-127	DICYCLOMINE HYDROCHLORIDE	Dicyclomine Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current
72266-127	DICYCLOMINE HYDROCHLORIDE	Dicyclomine Hydrochloride	Fosun Pharma USA Inc.	ANDA	Current