Application 073314

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	SUPPOSITORY;RECTAL	50MG	No	Yes

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
A073314-001	INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073314-001	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 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	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL	AB	RS	1992-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073314-001	INDOMETHACIN	50MG	SUPPOSITORY / RECTAL		RS	1992-08-31	`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	A073314-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073314-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073314-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073314-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073314-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073314-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073314-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073314-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073314-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073314-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073314-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073314-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073314-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073314-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073314-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073314-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073314-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073314-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073314-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A073314-001	AB	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
INDOCIN	INDOMETHACIN	Zyla Life Sciences US Inc.	3b36645c-de5e-4263-ae06-2f6ff6a9add2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073314 application number: ANDA073314 ndc (product): 69344-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0176	INDOMETHACIN	INDOMETHACIN	G & W LABORATORIES, INC.	ANDA	Current
0713-0176	INDOMETHACIN	INDOMETHACIN	Cosette Pharmaceuticals, Inc.	ANDA	Current
42211-102	INDOCIN	Indomethacin	Iroko Pharmaceuticals, LLC	ANDA	Current
69344-102	INDOCIN	Indomethacin	Zyla Life Sciences US Inc.	ANDA	Current
69344-102	INDOCIN	Indomethacin	Egalet US Inc.	ANDA	Current
69344-102	INDOCIN	Indomethacin	Zyla Life Sciences US Inc.	ANDA	Current
69344-102	INDOCIN	Indomethacin	Zyla Life Sciences US Inc.	ANDA	Current