Application 091118

Type: ANDA
Sponsor: SUN PHARM INDS 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 55MG BASE	No	No
003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG BASE	No	No
004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	No	No
005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE	No	No
006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG 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 135MG 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091118-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25
A091118-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03
A091118-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25
A091118-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25
A091118-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25
A091118-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03
A091118-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25

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 8 · 295 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091118-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091118-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091118-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091118-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091118-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091118-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091118-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2019-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091118-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091118-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091118-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2014-09-25	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091118-007	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091118-008	AB	1	`cb3db0bc1861…`

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 4 · 71 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	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e796794-b731-61d6-e063-6394a90aa9b3	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Major Pharamceuticals	fd86ff45-37d0-4501-b9fb-e1836e4a8be4	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	caa99901-467c-4e99-b7e9-fbabdf5d118c	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	0becbde8-6ec5-4830-a0d9-cfdb7b15eb84	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	093ff3c7-3ecc-47b4-9ae6-5218bcd262b2	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	65767ae3-b1ed-4492-90f2-703b2c7e0f38	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	87a137c6-dd53-44d3-ab49-ef78ebed35c8	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ec20539-0421-4eac-95ed-e9acc6329fd0	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7e2390b7-242c-43ff-afb3-b0a5e79351d3	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	c11bfea8-6079-44ce-b8e1-20bfba631bec	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6e0efd1a-5a09-4030-8fe2-f98334cdeb0e	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9c43389b-dc98-41f3-80bf-73d916ad6843	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	c7d0226e-5ac5-4fb1-9849-9d6663a2e8ad	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	bae17358-1180-4ca8-b163-f9a6f4f83a3d	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: MINOCYCLINE HYDROCHLORIDE generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	3539f84e-b489-4914-96c1-ac3731032971	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: MINOCYCLINE HYDROCHLORIDE generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	55df55fb-18ec-4e00-9ed0-10bba0da513b	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	409dddb0-be3a-4ae3-ab39-88a6cd50a219	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	b3236a5c-8a5d-4d5d-9656-aee72a4c482b	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a16012ce-5754-4177-bfb7-dcce696a7189	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Minocycline Hydrochloride generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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