Application 090867

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG 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	Approval date
A090867-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2013-05-13
A090867-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2013-05-13
A090867-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	2013-05-13

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	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2013-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2013-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2013-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2013-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2013-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2013-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2013-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2013-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090867-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2013-05-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A090867-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090867-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090867-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090867-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090867-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090867-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090867-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090867-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090867-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090867-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090867-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090867-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090867-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090867-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090867-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090867-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090867-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090867-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090867-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090867-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090867-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090867-001	AB	1	`5d02ea3f76ae…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	1229c84c-5627-4992-bb8a-7874b215c543	2023-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090867 application number: ANDA090867 ndc (product): 50090-5710
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	49e65b60-ffc9-4ccd-9aec-29a462358d27	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090867 application number: ANDA090867 ndc (product): 71205-511

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5710	Minocycline Hydrochloride	Minocycline Hydrochloride	A-S Medication Solutions	ANDA	Current
57664-851	Minocycline Hydrochloride	Minocycline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-852	Minocycline Hydrochloride	Minocycline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-853	Minocycline Hydrochloride	Minocycline Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68071-3307	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6997	Minocycline Hydrochloride	Minocycline Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70934-802	Minocycline Hydrochloride	Minocycline Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-511	Minocycline Hydrochloride	Minocycline Hydrochloride	Proficient Rx LP	ANDA	Current