Application 204101

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIFAMPIN	RIFAMPIN	INJECTABLE;INJECTION	600MG/VIAL	No	No

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

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
A204101-001	RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE / INJECTION			2014-08-18

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A204101-001	RIFAMPIN	600MG/VIAL	INJECTABLE / INJECTION	2014-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204101-001	RIFAMPIN	600MG/VIAL	INJECTABLE / INJECTION	2014-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204101-001	RIFAMPIN	600MG/VIAL	INJECTABLE / INJECTION	2014-08-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204101-001	RIFAMPIN	600MG/VIAL	INJECTABLE / INJECTION	2014-08-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204101-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204101-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204101-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204101-001	AP	1	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rifampin	RIFAMPIN	Mylan Institutional LLC	8be91604-d7cd-4f2b-997d-e3364e4092e5	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Rifampin generic name: RIFAMPIN
rifampin	RIFAMPIN	Bryant Ranch Prepack	0cb75e95-d165-4580-9340-42d7a9fd546e	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: rifampin generic name: RIFAMPIN
rifampin	RIFAMPIN	Major Pharmaceuticals	3f3534c1-95e4-4bdd-b044-9026e4addf0c	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: rifampin generic name: RIFAMPIN
rifampin	RIFAMPIN	Lupin Pharmaceuticals, Inc.	b56004f0-f23d-47f6-80c7-39884fccbccc	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: rifampin generic name: RIFAMPIN
rifampin	RIFAMPIN	A-S Medication Solutions	d53b6998-6e3b-4c6f-8465-2af6897d1efe	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: rifampin generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	Coupler LLC	410a314f-83bf-d9b3-e063-6294a90a872c	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: RIFAMPIN generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	28109dee-3e5e-492b-b7d9-9ba46c0b5324	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: RIFAMPIN generic name: RIFAMPIN
Rifampin	RIFAMPIN	ANI Pharmaceuticals, Inc.	b389b1a3-672f-47e3-916c-4a9c044b211b	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Rifampin generic name: RIFAMPIN
RIFAMPIN	RIFAMPIN	EPIC PHARMA, LLC	0391f1e1-70d4-4b15-8b58-055bb6a385b8	2023-12-20	Warnings, Adverse reactions	Name fallback brand name: RIFAMPIN generic name: RIFAMPIN
Rifampin	RIFAMPIN	Chartwell RX, LLC	4c39ee75-ae96-456d-bf47-16d49865345e	2023-04-12	Warnings, Adverse reactions	Name fallback brand name: Rifampin generic name: RIFAMPIN
Rifampin	RIFAMPIN	Fresenius Kabi USA, LLC	a1f9f1e2-dfc0-4d31-a13b-b656d897b791	2022-08-29	Warnings, Adverse reactions	Name fallback brand name: Rifampin generic name: RIFAMPIN
Rifampin	RIFAMPIN	Hikma Pharmaceuticals USA Inc.	cb59a48c-f66b-4ea0-809c-de0e4be2f8c2	2022-01-28	Warnings, Adverse reactions	Name fallback brand name: Rifampin generic name: RIFAMPIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-340	Rifampin	Rifampin	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-340	Rifampin	Rifampin	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current