Application 063065

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG BASE	No	No
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A063065-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		1991-12-30
A063065-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1999-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A063065-001	AB
A063065-002	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 3 · 82 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	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A063065-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063065-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063065-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063065-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063065-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063065-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063065-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063065-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063065-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063065-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063065-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063065-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063065-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063065-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063065-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063065-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063065-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063065-002	AB	1	`782e0a99824c…`

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 1 · 5 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.	87a137c6-dd53-44d3-ab49-ef78ebed35c8	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065 ndc (product): 55289-201
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	6597bdc9-9e3a-4c11-8b39-27b47f863287	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065 ndc (product): 0591-5695 ndc (product): 0591-3153
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6f154720-706e-4177-8167-1bc893303f1b	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065 ndc (product): 71335-1045

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
0591-3153	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3153	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-5695	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-5695	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
43353-105	Minocycline Hydrochloride	Minocycline Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
49999-505	Minocycline Hydrochloride	Minocycline Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0635	Minocycline Hydrochloride	Minocycline Hydrochloride	A-S Medication Solutions	ANDA	Current
55289-201	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-201	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-201	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-201	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-201	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
66336-377	Minocycline Hydrochloride	Minocycline Hydrochloride	Dispensing Solution, Inc.	ANDA	Current
67296-1181	Minocycline Hydrochloride	Minocycline Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1181	Minocycline Hydrochloride	Minocycline Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1181	Minocycline Hydrochloride	Minocycline Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-4216	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4216	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4227	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-2299	Minocycline Hydrochloride	Minocycline Hydrochloride	Carilion Materials Management	ANDA	Current
71335-1045	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39404	SUPPL	2004-06-09
18317	SUPPL	2004-06-09
42777	SUPPL	2003-08-27
22292	SUPPL	2003-08-27
22291	ORIG	2003-07-24
30617	SUPPL	1999-06-10
8348	SUPPL	1999-06-10