Application 075784

Type: ANDA
Sponsor: FRESENIUS KABI USA

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 1.

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
A075784-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2002-01-11
A075784-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2002-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075784-001	AP
A075784-002	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 · 82 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	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075784-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075784-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075784-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075784-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075784-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075784-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075784-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075784-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075784-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075784-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075784-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075784-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075784-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075784-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075784-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075784-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075784-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075784-002	AP	1	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	e46ebc7f-584e-e2b7-e053-2995a90ad17b	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 51662-1594
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	54dec321-b4c9-f0d6-e063-6294a90ae231	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	f335a030-ffa8-4f42-8166-2f06e036b40d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 55154-9368
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	63b73913-246d-4e5b-bdc9-c202980d8777	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 55154-9398
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	6758cb38-dec8-468f-94e2-613772e39b9a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 55154-9366
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	d1920335-8e45-4960-b6e9-e6f1f9e6820c	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-162 ndc (product): 63323-161
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	9e3ddc51-b572-8fe9-e053-2995a90a2f2a	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 71872-7185
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	2022-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-162 ndc (product): 63323-161
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ccf905ca-e164-4779-9485-2d139c821bad	2022-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-162 ndc (product): 63323-161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1594	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-9366	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health, Inc.	ANDA	Current
55154-9366	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	ANDA	Current
55154-9368	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health, Inc.	ANDA	Current
55154-9368	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health, Inc.	ANDA	Current
55154-9368	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health, Inc.	ANDA	Current
55154-9368	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	ANDA	Current
55154-9398	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health	ANDA	Current
55154-9398	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health	ANDA	Current
55154-9398	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health	ANDA	Current
55154-9398	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	ANDA	Current
55154-9398	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-161	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
63323-162	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ANDA	Current
70518-1091	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	ANDA	Current
70518-1340	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	ANDA	Current
70518-3369	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	ANDA	Current
70518-3369	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	ANDA	Current
71872-7185	Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	ANDA	Current