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 3 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	DIRECT RX	c3f35f80-e4ae-95f5-e053-2995a90a1b64	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	American Health Packaging	3f6b2c5a-e581-414f-bc9e-eaf66a5685cd	2025-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	12dea490-e179-f295-e063-6394a90af4aa	2025-04-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Brisk Pharmaceuticals	2de041be-1d36-ee95-e063-6294a90a2091	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2178249b-a9fe-5015-e063-6294a90a9ff4	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Quality Care Products, LLC	1d562ae9-5a9a-4fed-8cc7-3f30fb40f957	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	7b110bab-815e-4654-860b-b9142fd93d45	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2290109b-45c9-1aab-e063-6294a90a673b	2024-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	2b13d66d-4f48-477e-ba32-20e85d0e708d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7537fbab-c792-4b77-8736-c24b69cf48ea	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	8af1493c-1f22-4629-a432-f8b0578189e1	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	11e8dd9c-81fd-4e88-e063-6294a90af13e	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin Hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	bea7de4c-c077-4535-96a0-f6b319120b0b	2024-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b2bd8402-c887-5bfd-e053-2a95a90a15d9	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1d760cb7-d166-6707-e063-6394a90a8850	2024-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9e68cb17-73d9-8a00-e053-2995a90a517f	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9fe44bdd-eb59-4b55-e053-2995a90a3183	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN HYDROCHLORIDE generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	678912ff-a0c1-171b-e053-2991aa0ad128	2024-06-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	63f26644-b7ab-98c1-e053-2a91aa0af5d3	2024-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin hydrochloride generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	A-S Medication Solutions	2393251d-33b9-4274-9d04-27ec9968eaa1	2024-05-20	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