Application 204453

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE	No	No
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	No	No
004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	No	No
005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE	No	No
006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG BASE	No	No
007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 115MG BASE	No	No
008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 55MG 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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204453-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28
A204453-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16
A204453-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16
A204453-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A204453-001	AB
A204453-002	AB
A204453-003	AB
A204453-004	AB
A204453-005	AB
A204453-006	AB
A204453-007	AB
A204453-008	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 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 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	A204453-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204453-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-008	AB	1	`b8a1b40f171c…`

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
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e74e8a3-2670-97f5-e063-6394a90a361e	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e796794-b731-61d6-e063-6394a90aa9b3	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	c11bfea8-6079-44ce-b8e1-20bfba631bec	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6e0efd1a-5a09-4030-8fe2-f98334cdeb0e	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 63629-9208
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9c43389b-dc98-41f3-80bf-73d916ad6843	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 63629-9209
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	409dddb0-be3a-4ae3-ab39-88a6cd50a219	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	b3236a5c-8a5d-4d5d-9656-aee72a4c482b	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a16012ce-5754-4177-bfb7-dcce696a7189	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	99825095-d897-4077-86df-483d505615b2	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	493bdeac-e073-4ec2-a481-85e6a6d3cb58	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	74946a91-b138-42cd-a9d4-58fe8f849270	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	653b22f3-9eb5-4c29-9b95-bc1c4f0273be	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e1611d28-0c96-4ce2-ad5d-f62f66ec164d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Ascend Laboratories, LLC	a8f95207-b259-4f50-87f2-3652d9268890	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 67877-576 ndc (product): 67877-437 ndc (product): 67877-438 ndc (product): 67877-578 ndc (product): 67877-643 ndc (product): 67877-436 ndc (product): 67877-644 ndc (product): 67877-577
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e69284bc-0479-48d0-beb5-a26cfad6cd76	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	2688e63a-09c7-4d73-a923-cf14fec7b1a4	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	ddd22f2c-050b-4776-912b-39b3e6202c75	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f4139e4-d4ab-46ea-a3f1-f719ab57a55e	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 63629-9214
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	084fb405-fcb9-4db9-8d95-5a9c1d89f3b6	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 63629-9215
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	100b48e9-0884-4112-b9aa-cb6f07c28756	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 63629-9211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-9208	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9208	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9209	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9209	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9210	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9210	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9211	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9211	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9212	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9212	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9213	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9213	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9214	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9214	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9215	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-9215	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67877-436	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-436	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-437	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-437	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-437	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-438	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-438	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-438	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-576	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-576	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-576	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-577	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-577	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-577	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-578	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-578	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-578	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-643	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-643	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-643	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-644	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-644	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-644	Minocycline Hydrochloride	Minocycline Hydrochloride	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53620	ORIG	2018-04-05