Application 063067

Type: ANDA
Sponsor: CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DYNACIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG BASE	No	No
002	DYNACIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
003	DYNACIN	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A063067-001	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31
A063067-002	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15
A063067-003	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14

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 · 129 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	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063067-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063067-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063067-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063067-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063067-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063067-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063067-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063067-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063067-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063067-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063067-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063067-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063067-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063067-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063067-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063067-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063067-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063067-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063067-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063067-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063067-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063067-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063067-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063067-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063067-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063067-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063067-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063067-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063067-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063067-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063067-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063067-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063067-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063067-001	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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arestin	MINOCYCLINE HYDROCHLORIDE	OraPharma, Inc.	8515df41-1936-4f3b-86ba-d2bb2a8441fb	2024-05-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	192327c5-d2bc-1bd1-e063-6394a90a110b	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	1229c84c-5627-4992-bb8a-7874b215c543	2023-09-17	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	4f904969-5af3-461e-b557-d03a1e5c7292	2023-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d5fcba91-6aa6-4072-aea5-fb8da65d9aac	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	49e65b60-ffc9-4ccd-9aec-29a462358d27	2022-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d67e4b17-7d44-4d72-9150-420d98cc6db3	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-544	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-544	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-544	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-544	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-545	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-545	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-545	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-545	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-545	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-546	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-546	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-546	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-546	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
47781-546	minocycline hydrochloride	minocycline hydrochloride	Alvogen, Inc.	ANDA	Current
50090-3644	minocycline hydrochloride	minocycline hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3697	minocycline hydrochloride	minocycline hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3697	minocycline hydrochloride	minocycline hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3697	minocycline hydrochloride	minocycline hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3697	minocycline hydrochloride	minocycline hydrochloride	A-S Medication Solutions	ANDA	Current
68071-5262	minocycline hydrochloride	minocycline hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5262	minocycline hydrochloride	minocycline hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-775	minocycline hydrochloride	minocycline hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current