Application 207402

Type: ANDA
Sponsor: MICRO LABS

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 1.

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
A207402-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05
A207402-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05
A207402-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207402-001	AB
A207402-002	AB
A207402-003	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 · 123 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	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2018-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207402-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2018-11-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207402-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207402-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207402-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207402-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207402-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207402-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207402-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207402-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207402-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207402-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207402-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207402-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207402-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207402-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207402-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207402-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207402-001	AB	1	`8072bd15b7f6…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	f4c4fce0-0472-45a3-b4c6-192d97ca1818	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 70518-2153
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8e3c9cf6-ab39-4fb5-94e3-232880c47700	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 72789-167
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	de7001d1-8b83-4f8b-8e50-c07691021456	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	5f6a85c5-dca3-49b1-a029-3818a41d49bf	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 71335-1489
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	afeb96ed-7c2e-72d3-e053-2995a90a4ed3	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 60760-487
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Micro Labs Limited	9b9f898f-6a91-44f8-9508-f9ddfaad27bc	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 42571-250 ndc (product): 42571-251 ndc (product): 42571-252
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	bde81d4b-ad21-cc09-e053-2995a90a8c01	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 68071-2372
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ba9bd5cd-036b-4b0c-e053-2a95a90a332e	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 68071-2346
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	RedPharm Drug, Inc.	a2f6fa76-a114-4104-e053-2a95a90a9e0b	2026-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 67296-1749
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Northwind Health Company, LLC	f6f5c8b2-83a1-5362-e053-6394a90aaaad	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	cd2ca915-5672-440d-a14e-b4d3b6a522f3	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	DIRECT RX	c3f35f80-e4ae-95f5-e053-2995a90a1b64	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 72189-189
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Quality Care Products, LLC	1d562ae9-5a9a-4fed-8cc7-3f30fb40f957	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 55700-761
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	bea7de4c-c077-4535-96a0-f6b319120b0b	2024-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 71335-1412
Clindamycin hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	b2bd8402-c887-5bfd-e053-2a95a90a15d9	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 68071-2286
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1d760cb7-d166-6707-e063-6394a90a8850	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9e68cb17-73d9-8a00-e053-2995a90a517f	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 68071-5174
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9fe44bdd-eb59-4b55-e053-2995a90a3183	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 68071-5189
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	AvPAK	b2a810f1-c009-e973-e053-2a95a90ad5b0	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402 ndc (product): 50268-185
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	Asclemed USA, Inc.	7d3e6ec5-93e9-4ce0-8276-b19aa97eb772	2023-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207402 application number: ANDA207402

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 90 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-250	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-251	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
42571-252	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Micro Labs Limited	ANDA	Current
50090-4575	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4575	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4661	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4661	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	A-S Medication Solutions	ANDA	Current
50268-185	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	AvPAK	ANDA	Current
50268-185	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	AvPAK	ANDA	Current
53002-0622	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2321	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-761	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-761	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-761	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Quality Care Products, LLC	ANDA	Current
60760-427	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-487	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-487	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-487	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	St. Mary's Medical Park Pharmacy	ANDA	Current
67296-1702	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1702	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1702	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1749	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1749	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1749	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-2286	Clindamycin hydrochloride	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2286	Clindamycin hydrochloride	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2346	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2372	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5174	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5174	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5189	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5189	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5189	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5189	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5189	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7753	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7753	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7753	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2153	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-626	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-444	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Proficient Rx LP	ANDA	Current
71205-444	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Proficient Rx LP	ANDA	Current
71205-444	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Proficient Rx LP	ANDA	Current
71205-444	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Proficient Rx LP	ANDA	Current
71205-444	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Proficient Rx LP	ANDA	Current
71335-1412	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1412	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1412	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1412	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1489	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1489	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1489	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-189	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	DIRECT RX	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-167	CLINDAMYCIN HYDROCHLORIDE	Clindamycin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current