Application 216957

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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
A216957-001	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10
A216957-002	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10
A216957-003	CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216957-001	AB
A216957-002	AB
A216957-003	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 2 · 75 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	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-002	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-003	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE / ORAL	AB	2023-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-001	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2023-03-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A216957-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216957-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216957-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216957-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216957-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216957-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216957-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216957-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216957-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216957-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216957-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216957-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216957-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216957-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216957-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216957-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216957-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216957-001	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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2290109b-45c9-1aab-e063-6294a90a673b	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957
Clindamycin Hydrochloride	CLINDAMYCIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	11e8dd9c-81fd-4e88-e063-6294a90af13e	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216957 application number: ANDA216957

Reported adverse events (FAERS/openFDA)#

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