Application 211941

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	INJECTABLE;INJECTION	EQ 0.25MG BASE/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
A211941-001	CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP		2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211941-001	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	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211941-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-02	`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	A211941-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211941-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211941-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211941-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211941-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211941-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211941-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211941-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211941-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211941-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211941-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211941-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211941-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211941-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211941-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211941-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211941-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211941-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211941-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211941-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211941-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211941-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211941-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211941-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211941-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211941-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211941-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211941-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211941-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211941-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211941-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211941-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211941-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211941-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211941-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211941-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211941-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211941-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211941-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211941-001	AP	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211941-001	CGT	2019-12-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211941-001	CGT	2019-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211941-001	CGT	2019-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211941-001	CGT	2019-12-29	`ea99ee380514…`

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
Carboprost Tromethamine	CARBOPROST TROMETHAMINE	Dr. Reddy's Laboratories Inc.	ce9f0ea6-69f9-6b68-2811-3b51e34acea6	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 211941 application number: ANDA211941 ndc (product): 43598-698
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	Dr. Reddys Laboratories Inc.	2fd306a6-bf50-a354-46e5-d9fa8da619af	2024-12-20	Adverse reactions	Exact identifier application applno (ANDA): 211941 application number: ANDA211941 ndc (product): 43598-919
CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	Dr. Reddys Laboratories Inc.	1fc164ae-9964-17b3-4b92-d25b0ddb805e	2024-12-19	Adverse reactions	Exact identifier application applno (ANDA): 211941 application number: ANDA211941 ndc (product): 43598-917

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
43598-698	Carboprost Tromethamine	Carboprost Tromethamine	Dr. Reddy	ANDA	Current
43598-917	CARBOPROST TROMETHAMINE	carboprost tromethamine	Dr. Reddy	ANDA	Current
43598-919	CARBOPROST TROMETHAMINE	carboprost tromethamine	Dr. Reddy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59611	ORIG	2019-08-07