Application 063009

Type: ANDA
Sponsor: ZYDUS

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	Yes
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
A063009-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02
A063009-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063009-001	AB
A063009-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063009-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1992-03-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063009-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		2003-08-12	`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	A063009-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063009-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063009-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063009-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063009-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063009-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063009-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063009-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063009-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063009-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063009-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063009-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063009-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063009-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063009-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063009-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063009-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063009-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063009-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063009-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063009-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063009-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063009-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063009-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063009-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063009-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063009-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063009-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063009-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063009-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063009-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063009-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063009-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063009-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063009-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063009-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063009-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063009-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063009-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	0760232b-21a6-2b13-e063-6394a90a22c1	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063009 application number: ANDA063009
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	25acb785-6838-4e62-9e86-ddc30b2b759a	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063009 application number: ANDA063009 ndc (product): 68382-317 ndc (product): 68382-318
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	26ee99af-f44b-4076-a08c-0a0dedc9edfe	2024-10-03		Exact identifier application applno (ANDA): 063009 application number: ANDA063009 ndc (product): 70771-1428 ndc (product): 70771-1427

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-317	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-317	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-317	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-318	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-318	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-318	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70518-2943	Minocycline hydrochloride	Minocycline hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2943	Minocycline hydrochloride	Minocycline hydrochloride	REMEDYREPACK INC.	ANDA	Current
70771-1427	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1427	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1427	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1427	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1428	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1428	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1428	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1428	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1428	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8347	SUPPL	2014-02-24
18316	SUPPL	2014-02-21