Application 203553

Type: ANDA
Sponsor: ZYDUS PHARMS

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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203553-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16

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 · 284 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	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A203553-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203553-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203553-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203553-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203553-008	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203553-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203553-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203553-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203553-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203553-008	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203553-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203553-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203553-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203553-006	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203553-008	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203553-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203553-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203553-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203553-006	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203553-008	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203553-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203553-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203553-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203553-006	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203553-008	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A203553-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-006	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-007	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A203553-008	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-006	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203553-007	AB	1	`a72a2bbeb626…`

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	Zydus Lifesciences Limited	8bf9cf23-8ffc-401f-981d-4878d694a468	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203553 application number: ANDA203553 ndc (product): 70771-1156 ndc (product): 70771-1157 ndc (product): 70771-1138 ndc (product): 70771-1167 ndc (product): 70771-1155
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	85f082a5-bba1-4441-ba28-4b8ec9a537f2	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203553 application number: ANDA203553 ndc (product): 68382-533 ndc (product): 68382-551 ndc (product): 68382-531 ndc (product): 68382-535 ndc (product): 68382-552

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-531	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-531	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-533	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-533	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-535	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-535	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-551	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-551	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-552	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-552	minocycline hydrochloride	minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1138	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1138	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1155	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1155	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1156	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1156	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1157	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1157	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1167	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1167	minocycline hydrochloride	minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50727	ORIG	2017-12-18