Application 215212

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEROPENEM	MEROPENEM	POWDER;INTRAVENOUS	2GM/VIAL	Yes	Yes

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

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
N215212-001	MEROPENEM	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N215212-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2023-07-26	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215212-001	MEROPENEM	2GM/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2023-07-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N215212-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215212-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215212-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215212-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215212-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215212-001	AP	1	`a50c72e98297…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meropenem	MEROPENEM	Hikma Pharmaceuticals USA Inc.	8a2a545e-b336-416a-be73-9e0a7ccf6177	2026-08-26	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Sagent Pharmaceuticals	e8848f4a-bca9-4978-b0a1-38483fd4d639	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	BluePoint Laboratories	ca5f501c-6520-4d09-aae2-4f5db74d468f	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
MEROPENEM	MEROPENEM	Savior Lifetec Corporation	31dd2160-7dbd-51fa-e054-00144ff88e88	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: MEROPENEM generic name: MEROPENEM
MEROPENEM	MEROPENEM	Sandoz Inc	0d37e43b-ff8d-495d-b9af-4fd5fce53d56	2025-11-14	Warnings, Adverse reactions	Name fallback brand name: MEROPENEM generic name: MEROPENEM
Meropenem	MEROPENEM	Qilu Antibiotics Pharmaceutical Co., Ltd.	1f9591ed-3a6c-422e-b1be-7b3e4fe5bf3c	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Civica, Inc.	35466216-55ed-4836-8cbc-c8aafb079dae	2025-09-12	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
MEROPENEM	MEROPENEM	Civica, Inc	b0075b72-c3cc-f844-e053-2a95a90a417f	2025-09-10	Warnings, Adverse reactions	Name fallback brand name: MEROPENEM generic name: MEROPENEM
Meropenem	MEROPENEM	BROOKS STERISCIENCE LIMITED	58e165b7-e230-4459-abf9-06d5ca1dd7b2	2025-07-31	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Eugia US LLC	bf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	BROOKS STERISCIENCE LIMITED	6902fee1-6022-4145-a79a-4680ad1fb1e8	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Gland Pharma Limited	4e4e2c0c-df54-4229-ab90-fa671ecedd57	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Amneal Pharmaceuticals LLC	a456013b-b20e-4b29-b2f9-06f18f1ea6bd	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Hikma Pharmaceuticals USA Inc.	d54fdbad-ca93-467c-92d7-c1bd88f3bbe3	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Mylan Institutional LLC	f5154b6f-bca8-4f1e-907b-48ea34caf483	2024-12-25	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Hospira, Inc.	e9b6555f-20a1-4415-bb80-3d034cfab95b	2024-11-06	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	Hospira, Inc.	092ebd9b-77a0-4877-afc3-dd8211730f71	2024-11-06	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
MEROPENEM	MEROPENEM	Xellia Pharmaceuticals USA LLC	06d84c55-94ff-46e5-8477-b8881c12eb0a	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: MEROPENEM generic name: MEROPENEM
Meropenem	MEROPENEM	ARMAS PHARMACEUTICALS INC	e1122310-c3ed-42f1-b189-301c221ff1f0	2022-07-29	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM
Meropenem	MEROPENEM	WG Critical Care, LLC	6520ae3d-e149-499c-8152-36f6ab861662	2021-06-30	Warnings, Adverse reactions	Name fallback brand name: Meropenem generic name: MEROPENEM

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
80520	SUPPL	2024-12-05
80501	SUPPL	2024-12-04
77824	ORIG	2024-03-14
74907	ORIG	2023-07-28
74908	ORIG	2023-07-27