Application 070607

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN	ACETAMINOPHEN	SUPPOSITORY;RECTAL	120MG	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
A070607-001	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL			1987-04-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070607-001	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	1987-04-06	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fever reducing childrens	ACETAMINOPHEN	CVS Pharmacy	9d89544f-3a66-4f23-b609-381d027e0c95	2025-06-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 59779-579
Foster and Thrive Pain Reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	0a7d82f8-7615-4cef-b245-94b186f3c8fa	2025-04-07	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607
acetaminophen for children	ACETAMINOPHEN	A-S Medication Solutions	a9864f73-abb2-4cb1-a692-a48efdeeedf8	2025-01-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 50090-0001
acetaminophen for children	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	62b3d354-d7f5-4ba0-b233-ea6be0d7ff03	2024-12-17	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 45802-732
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	5f86e792-3262-4ee6-e053-2991aa0a54a0	2024-06-06	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 68071-4172
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceutiacals,Inc.	5d7ef1d2-d970-7b01-e053-2991aa0a1311	2024-06-04	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 68071-4151
pain reliever fever reducer childrens	ACETAMINOPHEN	Walgreen Company	f2085b26-5778-4656-8de3-9edd83f914dd	2023-05-03	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 0363-0579
acetaminophen for children	ACETAMINOPHEN	Proficient Rx LP	43fd900c-50c8-49c4-9f07-4fef924d533c	2022-09-01	Warnings	Exact identifier application applno (ANDA): 070607 application number: ANDA070607 ndc (product): 63187-373

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0579	pain reliever fever reducer	Acetaminophen	Walgreen Company	ANDA	Current
0363-0706	childrens fever reducer	Acetaminophen	Walgreen Company	ANDA	Current
0363-0706	childrens fever reducer	Acetaminophen	Walgreen Company	ANDA	Current
0363-0706	childrens fever reducer	Acetaminophen	Walgreen Company	ANDA	Current
45802-732	acetaminophen	Acetaminophen	Perrigo New York Inc	ANDA	Current
45802-732	acetaminophen	Acetaminophen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-732	acetaminophen	Acetaminophen	Perrigo New York Inc	ANDA	Current
50090-0001	acetaminophen	Acetaminophen	A-S Medication Solutions	ANDA	Current
59779-579	fever reducing	Acetaminophen	CVS Pharmacy	ANDA	Current
59779-579	fever reducing	Acetaminophen	CVS Pharmacy	ANDA	Current
63187-373	acetaminophen	Acetaminophen	Proficient Rx LP	ANDA	Current
63187-373	acetaminophen	Acetaminophen	Proficient Rx LP	ANDA	Current
63187-373	acetaminophen	Acetaminophen	Proficient Rx LP	ANDA	Current
63187-373	acetaminophen	Acetaminophen	Proficient Rx LP	ANDA	Current
68071-4151	acetaminophen	Acetaminophen	NuCare Pharmaceutiacals,Inc.	ANDA	Current
68071-4151	acetaminophen	Acetaminophen	NuCare Pharmaceutiacals,Inc.	ANDA	Current
68071-4151	acetaminophen	Acetaminophen	NuCare Pharmaceutiacals,Inc.	ANDA	Current
68071-4172	acetaminophen	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4172	acetaminophen	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4172	acetaminophen	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4172	acetaminophen	Acetaminophen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-0426	acetaminophen	Acetaminophen	Preferred Pharmaceuticals, Inc.	ANDA	Current