Application 065092

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANICLOR	CEFACLOR	TABLET, CHEWABLE;ORAL	EQ 125MG BASE	No	No
002	RANICLOR	CEFACLOR	TABLET, CHEWABLE;ORAL	EQ 187MG BASE	No	No
003	RANICLOR	CEFACLOR	TABLET, CHEWABLE;ORAL	EQ 250MG BASE	No	No
004	RANICLOR	CEFACLOR	TABLET, CHEWABLE;ORAL	EQ 375MG BASE	No	No

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

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	Approval date
A065092-001	RANICLOR	CEFACLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22
A065092-002	RANICLOR	CEFACLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22
A065092-003	RANICLOR	CEFACLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22
A065092-004	RANICLOR	CEFACLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065092-001	RANICLOR	EQ 125MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065092-002	RANICLOR	EQ 187MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065092-003	RANICLOR	EQ 250MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065092-004	RANICLOR	EQ 375MG BASE	TABLET, CHEWABLE / ORAL	2003-12-22	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefaclor	CEFACLOR	Carlsbad Technology, Inc.	2f61354e-bcb0-41aa-955f-51eabc11387b	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: CEFACLOR
Cefaclor	CEFACLOR	A-S Medication Solutions	d79a4b28-ef2b-4f0f-baec-002df7d06dd4	2024-01-31	Warnings, Adverse reactions	Name fallback generic name: CEFACLOR
Cefaclor	CEFACLOR	Azorian Pharma, LLC	224af904-38f3-4210-a750-e21006db4c66	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: CEFACLOR
Cefaclor	CEFACLOR	Teva Pharmaceuticals USA, Inc.	0878bdc2-0410-4938-9890-96523aa81c2f	2019-07-31	Warnings, Adverse reactions	Name fallback generic name: CEFACLOR

Reported adverse events (FAERS/openFDA)#

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