Application 064153

Type: ANDA
Sponsor: X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACIIM	BACITRACIN	INJECTABLE;INJECTION	50,000 UNITS/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog.

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	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	1997-05-09	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064153-001	BACIIM	50,000 UNITS/VIAL	INJECTABLE / INJECTION		1997-05-09	`cb3db0bc1861…`

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	A064153-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A064153-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064153-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064153-001	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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Name fallback generic name: BACITRACIN
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Name fallback generic name: BACITRACIN
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Name fallback generic name: BACITRACIN
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Padagis Israel Pharmaceuticals Ltd	bebbedf6-dd65-47a4-aa3e-ad197b3e05a1	2024-07-31	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	NuCare Pharmaceuticals,Inc.	a526ae4b-baae-5d50-e053-2a95a90ae293	2024-07-17	Warnings	Name fallback generic name: BACITRACIN
Major Bacitracin	BACITRACIN	Major Pharmaceuticals	13288efb-e282-68f8-e063-6294a90ae712	2024-03-08	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Name fallback generic name: BACITRACIN
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Name fallback generic name: BACITRACIN

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
39822-0277	BACiiM	Bacitracin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0277	BACiiM	Bacitracin	X-GEN Pharmaceuticals, Inc.	ANDA	Current