Application 080448

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A080448-001	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL		Approved before 1982
A080448-002	MEPERIDINE HYDROCHLORIDE	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL		Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080448-001	MEPERIDINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080448-002	MEPERIDINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`

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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76071	ORIG	2023-11-02