Application 065217

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	No	No
003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 300MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065217-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31
A065217-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31
A065217-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065217-001	AB
A065217-002	AB
A065217-003	AB

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 4 · 129 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
2026-09-14 22:38:34	2026-08	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2005-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2005-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065217-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2005-01-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065217-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065217-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065217-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065217-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065217-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065217-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065217-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065217-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065217-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065217-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065217-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065217-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065217-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065217-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065217-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065217-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065217-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065217-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065217-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065217-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065217-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065217-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065217-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065217-001	AB	1	`301d65b070ca…`

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	87db8bce-1b6f-4f1b-ab62-b3778c429b2e	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f0ddf1a-eda6-8ca8-e063-6294a90a4102	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	51dfa3fa-6f6a-4904-a8d3-b5938cf9c852	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	adf8f0fa-f794-4e97-a7b3-16b55d9c9a68	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	8e66de7a-d9d4-4562-bc99-80489d482da4	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	bde81d4b-ad21-cc09-e053-2995a90a8c01	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ba9bd5cd-036b-4b0c-e053-2a95a90a332e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Sportpharm LLC	3bddb5d2-ddac-2f03-e063-6294a90aa68c	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	ebdcd3ce-3140-4bf6-b8b8-468ead08d9a9	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	RedPharm Drug, Inc.	a2f6fa76-a114-4104-e053-2a95a90a9e0b	2026-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f2f08e98-f6c5-7c2d-e053-2995a90abe1e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f781897a-ab54-7373-e053-6294a90a89a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f6f5c8b2-83a1-5362-e053-6394a90aaaad	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4730ab20-09e2-d32a-e063-6394a90ae125	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Redpharm Drug	0a0fbeae-2bc2-2402-e063-6394a90a97a0	2025-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Redpharm Drug	3256c93b-f26c-aeb9-e063-6394a90ae9c2	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	VERITYRX, LLC	427a0138-c2dd-cf0b-e063-6394a90af407	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	09eea0ad-702f-4eea-bfb9-81effc76b22b	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	9fe68a5a-487b-4119-9ee7-603948d732e4	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	cd2ca915-5672-440d-a14e-b4d3b6a522f3	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-234	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-234	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-234	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-235	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-235	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-235	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-236	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-236	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-236	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1136	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1136	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1136	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1136	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1137	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1137	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1137	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1137	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1183	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1183	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1183	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1183	Clindamycin Hydrochloride	Clindamycin Hydrochloride	Cadila Healthcare Limited	ANDA	Current