Application 080455

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
007	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	No	No
008	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	50MG/ML	No	No
009	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	75MG/ML	No	No
010	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A080455-007	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080455-008	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080455-009	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080455-010	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A080455-007	AP
A080455-008	AP
A080455-009	AP
A080455-010	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 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080455-007	MEPERIDINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080455-008	MEPERIDINE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080455-009	MEPERIDINE HYDROCHLORIDE	75MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080455-010	MEPERIDINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A080455-007	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080455-008	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080455-009	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080455-010	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080455-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080455-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080455-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080455-010	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080455-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080455-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080455-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080455-010	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080455-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080455-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080455-009	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080455-010	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080455-007	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080455-008	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080455-009	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080455-010	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080455-007	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080455-008	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080455-009	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080455-010	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080455-007	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080455-008	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080455-009	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080455-010	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080455-007	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080455-008	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080455-009	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080455-010	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080455-007	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080455-008	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080455-009	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080455-010	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080455-007	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080455-008	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080455-009	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080455-010	AP	1	`5bbf6a4d5a75…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEMEROL	MEPERIDINE HYDROCHLORIDE	Hospira, Inc.	b31d1308-28c3-43f4-e0a6-2f3ed76b8975	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	15bc51a8-1e24-4d33-9a2f-05a41c29acf0	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meperidine Hydrochloride generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	Genus Lifesciences Inc.	792fefda-6cc4-4709-b902-fd9787fc310a	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meperidine Hydrochloride generic name: MEPERIDINE HYDROCHLORIDE
Meperidine Hydrochloride	MEPERIDINE HYDROCHLORIDE	EPIC PHARMA, LLC	fae5cc34-5917-4445-9516-25f97ffca8db	2025-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Meperidine Hydrochloride generic name: MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e0e998da-f056-4fce-be8e-ed60cf3b461b	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MEPERIDINE HYDROCHLORIDE generic name: MEPERIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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