Application 063181

Type: ANDA
Sponsor: WATSON LABS TEVA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A063181-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1991-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063181-001	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 2 · 41 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	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063181-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1991-12-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A063181-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063181-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063181-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063181-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063181-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063181-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063181-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063181-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063181-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063181-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063181-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063181-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063181-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063181-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063181-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063181-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063181-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063181-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063181-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063181-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063181-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063181-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063181-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063181-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063181-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063181-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063181-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063181-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063181-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063181-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063181-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063181-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063181-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063181-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063181-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063181-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063181-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063181-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063181-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063181-001	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 1 · 4 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.	1ec20539-0421-4eac-95ed-e9acc6329fd0	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063181 application number: ANDA063181 ndc (product): 55289-202
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063181 application number: ANDA063181 ndc (product): 0591-5694
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d5fcba91-6aa6-4072-aea5-fb8da65d9aac	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063181 application number: ANDA063181 ndc (product): 71205-086
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063181 application number: ANDA063181 ndc (product): 71335-0682

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5694	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-5694	Minocycline Hydrochloride	Minocycline Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
50090-0632	Minocycline Hydrochloride	Minocycline Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0632	Minocycline Hydrochloride	Minocycline Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0632	Minocycline Hydrochloride	Minocycline Hydrochloride	A-S Medication Solutions	ANDA	Current
53002-2880	Minocycline Hydrochloride	Minocycline Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2880	Minocycline Hydrochloride	Minocycline Hydrochloride	RPK Pharmaceuticals, Inc.	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-202	Minocycline Hydrochloride	Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55695-004	Minocycline Hydrochloride	Minocycline Hydrochloride	Department of State Health Services, Pharmacy Branch	ANDA	Current
63629-6422	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-6422	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-4163	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4163	Minocycline Hydrochloride	Minocycline Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0055	Minocycline Hydrochloride	Minocycline Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-086	Minocycline Hydrochloride	Minocycline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-086	Minocycline Hydrochloride	Minocycline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-086	Minocycline Hydrochloride	Minocycline Hydrochloride	Proficient Rx LP	ANDA	Current
71205-086	Minocycline Hydrochloride	Minocycline Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0682	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0682	Minocycline Hydrochloride	Minocycline Hydrochloride	Bryant Ranch Prepack	ANDA	Current