Application 204216

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	15MG/ML	No	No
002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	INJECTABLE;INJECTION	30MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204216-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2016-11-01
A204216-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2016-11-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204216-001	AP
A204216-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204216-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204216-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2016-11-01	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204216-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204216-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204216-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204216-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204216-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204216-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204216-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204216-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204216-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204216-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204216-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204216-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204216-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204216-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204216-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204216-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204216-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204216-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204216-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204216-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204216-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204216-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204216-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204216-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204216-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204216-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204216-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204216-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204216-002	AP	1	`74a2ff9319b5…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	2a23b0fa-803c-4abb-b588-12cfe83326a9	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	6f727e1f-2838-427b-a236-eeb0101b08f3	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	26a1761b-90bf-49c6-9e6a-f293af2296ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Direct_rx	22de8e1c-5e68-fd78-e063-6394a90ad40b	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	43d07956-90ba-4e96-b265-aec03eced19b	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 70518-2927
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Civica, Inc.	32198544-4a46-495c-ab65-0836dcbc2c49	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	42dfd39e-53a3-e9ee-e063-6394a90ab51e	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	5e42914f-de71-4176-819b-9fa26a8bdce6	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sagent Pharmaceuticals	62591551-a644-4b2c-a0de-982e906fabc3	2025-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	ProPharma Distribution	3f2956d9-9e68-f35e-e063-6394a90a706d	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	99c06dde-f218-4d81-91e0-f37a748872d6	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	1e65d11b-5aa9-4a6b-b5d6-c19828748fea	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Henry Schein, Inc.	606b0f2f-de28-42a9-96f4-cacba2c7c56a	2025-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
ketorolac tromethamine	KETOROLAC TROMETHAMINE	FOSUN PHARMA USA INC	1aae6a4d-0909-4672-aa26-e3f2d8c4d413	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 72266-118 ndc (product): 72266-119
ketorolac tromethamine	KETOROLAC TROMETHAMINE	Gland Pharma Limited	5abd4389-4fb2-408b-a27e-cf64b6a921f1	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ada639d4-babb-2ad0-e053-2a95a90afce7	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 71872-7213
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	e17f583d-8bd4-3ed0-e053-2a95a90a9090	2023-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 71872-7288
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	b88e562d-226b-4200-afa5-034e628c660f	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216
Ketorolac tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	ee44c322-4b4b-4397-a1a5-e5b3c3c5a053	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 76420-272
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	014ba8d7-7ed3-4d4a-847a-22b65161117e	2021-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204216 application number: ANDA204216 ndc (product): 71205-582

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 147 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2610	Ketorolac Tromethamine	ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-2610	Ketorolac Tromethamine	ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-2610	Ketorolac Tromethamine	ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-2927	Ketorolac tromethamine	Ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
70518-2927	Ketorolac tromethamine	Ketorolac tromethamine	REMEDYREPACK INC.	ANDA	Current
70529-119	Acunivive 15	KETOROLAC TROMETHAMINE	IT3 Medical LLC	ANDA	Current
70529-119	Acunivive 15	KETOROLAC TROMETHAMINE	IT3 Medical LLC	ANDA	Current
70529-120	Acunivive 30	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-120	Acunivive 30	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-120	Acunivive 30	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-121	Acunivive 60	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-121	Acunivive 60	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-121	Acunivive 60	ketorolac tromethamine	IT3 Medical LLC	ANDA	Current
70529-122	Acunivive 90	Ketorolac Tromethamine	IT3 Medical LLC	ANDA	Current
70529-122	Acunivive 90	Ketorolac Tromethamine	IT3 Medical LLC	ANDA	Current
70529-122	Acunivive 90	Ketorolac Tromethamine	IT3 Medical LLC	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-700	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-701	Ketorolac Tromethamine	ketorolac tromethamine	Athenex Pharmaceutical Division, LLC.	ANDA	Current
71205-116	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-116	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-582	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71205-594	Ketorolac Tromethamine	ketorolac tromethamine	Proficient Rx LP	ANDA	Current
71872-7131	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7131	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7132	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7132	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7212	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7213	Ketorolac tromethamine	Ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7234	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7287	Ketorolac Tromethamine	ketorolac tromethamine	Medical Purchasing Solutions, LLC.	ANDA	Current
71872-7288	Ketorolac tromethamine	Ketorolac tromethamine	Medical Purchasing Solutions, LLC	ANDA	Current
72266-118	ketorolac tromethamine	ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	ketorolac tromethamine	ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-118	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	ketorolac tromethamine	ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	ketorolac tromethamine	ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	ketorolac tromethamine	ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72266-119	Ketorolac tromethamine	Ketorolac tromethamine	Fosun Pharma USA Inc	ANDA	Current
72611-719	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-719	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-719	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-722	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-722	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-722	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-725	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-725	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
72611-725	Ketorolac Tromethamine	ketorolac tromethamine	Almaject, Inc.	ANDA	Current
76420-272	Ketorolac tromethamine	Ketorolac tromethamine	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45796	ORIG	2016-11-03