Application 074014

Type: ANDA
Sponsor: HERITAGE PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOPROFEN	KETOPROFEN	CAPSULE;ORAL	25MG	No	No
002	KETOPROFEN	KETOPROFEN	CAPSULE;ORAL	50MG	No	No
003	KETOPROFEN	KETOPROFEN	CAPSULE;ORAL	75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074014-001	KETOPROFEN	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29
A074014-002	KETOPROFEN	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29
A074014-003	KETOPROFEN	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074014-002	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 4 · 123 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	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-002	KETOPROFEN	50MG	CAPSULE / ORAL	AB		1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-003	KETOPROFEN	75MG	CAPSULE / ORAL		RS	1993-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074014-001	KETOPROFEN	25MG	CAPSULE / ORAL			1993-01-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 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	A074014-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074014-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074014-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074014-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074014-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074014-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074014-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074014-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074014-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074014-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074014-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074014-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074014-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074014-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074014-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074014-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074014-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074014-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074014-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074014-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074014-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074014-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074014-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074014-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074014-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074014-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074014-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074014-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074014-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074014-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074014-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074014-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074014-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074014-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074014-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074014-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074014-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074014-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074014-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074014-002	AB	1	`9b2671bbb829…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoprofen	KETOPROFEN	Marnel Pharmaceuticals, Inc.	4e7bceb6-dcb5-c5e0-e063-6294a90a101e	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014
Ketoprofen	KETOPROFEN	Oncora Pharma, LLC	492de5dc-7c1b-47be-8510-43be4e1fd4ed	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014
Ketoprofen	KETOPROFEN	Misemer Pharmaceuticals, Inc.	d0f47ab6-29ff-df07-e053-2a95a90a2b51	2026-02-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014 ndc (product): 0276-0504 ndc (product): 0276-0506
Orudis	KETOPROFEN	Allegis Pharmaceuticals, Inc.	47d0b808-7142-c7a9-e063-6394a90a6e0d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074014 application number: ANDA074014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0276-0504	Ketoprofen	Ketoprofen	Misemer Pharmaceuticals, Inc.	ANDA	Current
0276-0504	Ketoprofen	Ketoprofen	Misemer Pharmaceuticals, Inc.	ANDA	Current
0276-0504	Ketoprofen	Ketoprofen	Misemer Pharmaceuticals, Inc.	ANDA	Current
0276-0504	Ketoprofen	Ketoprofen	Misemer Pharmaceuticals, Inc.	ANDA	Current
0276-0506	Ketoprofen	Ketoprofen	Misemer Pharmaceuticals, Inc.	ANDA	Current
23155-020	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-020	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-020	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-020	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-020	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-020	Ketoprofen	Ketoprofen	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-021	ketoprofen	ketoprofen	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-022	ketoprofen	ketoprofen	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	ANDA	Current
69336-127	Ketoprofen	Ketoprofen	Sterling-Knight Pharmaceuticals LLC	ANDA	Current
69336-127	Ketoprofen	Ketoprofen	Sterling-Knight Pharmaceuticals LLC	ANDA	Current
69336-127	Ketoprofen	Ketoprofen	STERLING-KNIGHT PHARMACEUTICALS, LLC	ANDA	Current