Application 065178

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	500MG	No	No
002	CLARITHROMYCIN	CLARITHROMYCIN	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065178-001	CLARITHROMYCIN	CLARITHROMYCIN	500MG	TABLET / ORAL			2004-05-25
A065178-002	CLARITHROMYCIN	CLARITHROMYCIN	250MG	TABLET / ORAL			2004-05-25

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 1 of 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL	AB	2004-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065178-001	CLARITHROMYCIN	500MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065178-002	CLARITHROMYCIN	250MG	TABLET / ORAL		2004-05-25	`782e0a99824c…`

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	A065178-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065178-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065178-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065178-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065178-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065178-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065178-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065178-002	AB	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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	PD-Rx Pharmaceuticals, Inc.	ba216276-b0bd-420a-9e0d-090bdfcc2460	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	25debd85-0840-4f8d-9898-027772061dd2	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
clarithromycin	CLARITHROMYCIN	Actavis Pharma, Inc.	d5be5f12-6392-4d7d-ab23-ebc205ac1a85	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Coupler LLC	2d6cfd87-9b8c-bba9-e063-6294a90aff5a	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	NuCare Pharmaceuticals,Inc.	9143b79c-4c79-43ac-e053-2995a90ad708	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	DirectRx	d22bd12c-737b-4aab-e053-2995a90aff60	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	27e02b77-4332-49e0-8d0c-a072cf5dff92	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Proficient Rx LP	28f60574-4ecd-441c-aebe-5b1d18033ef6	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Bryant Ranch Prepack	0c7d8391-50ef-4827-abe6-e0fc0c2f1636	2024-01-16	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Rising Pharma Holdings, Inc.	0c4db97f-f4c9-4cac-9f12-9db1d967ebeb	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	adba78c2-9e51-4bed-8c6a-6f977f79c40c	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7	2023-11-13	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Aurobindo Pharma Limited	9aaffb41-408c-4372-8fd5-1d649450c0e9	2023-10-10	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Lannett Company, Inc.	71a836d0-d60f-6418-e053-2a95a90aa6ef	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	22457862-0f88-4be8-b507-1c8f264269f2	2023-09-13	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	A-S Medication Solutions	1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23	2023-07-31	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Sandoz Inc	b98b02bb-2609-49a0-b29f-e5911aa0cbc1	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Alembic Pharmaceuticals Limited	268d21f9-02c9-41b0-9487-7968ea12720d	2023-05-29	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
Clarithromycin	CLARITHROMYCIN	Alembic Pharmaceuticals Inc.	cde51c9f-f7b8-413f-8b8e-e56370cd5754	2023-05-26	Warnings, Adverse reactions	Name fallback brand name: Clarithromycin generic name: CLARITHROMYCIN
CLARITHROMYCIN	CLARITHROMYCIN	Chartwell RX, LLC.	99d2fd6b-39ca-42f9-ad06-30e7fbc22c47	2022-12-23	Warnings, Adverse reactions	Name fallback brand name: CLARITHROMYCIN generic name: CLARITHROMYCIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0036	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0037	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0037	Clarithromycin	clarithromycin	West-Ward Pharmaceuticals Corp.	ANDA	Current
10544-952	Clarithromycin	clarithromycin	Blenheim Pharmacal, Inc.	ANDA	Current
63629-2887	Clarithromycin	clarithromycin	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23737	ORIG	2006-03-03