Application 062337

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062337-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1982-03-29
A062337-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1982-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062337-001	AB
A062337-002	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 3 · 82 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	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1982-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1982-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1982-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1982-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1982-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1982-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062337-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL		1982-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062337-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL		1982-03-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062337-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062337-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062337-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062337-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062337-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062337-002	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062337-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062337-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	3af9348c-a98b-4059-a5ef-4229e2b33af0	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	1401d590-0967-4c6b-b52b-a83e9f6df097	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	HAWAII REPACK, INC	88c429a1-351d-432e-b69b-d7a0afca482a	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Chartwell RX, LLC	fad03768-f1d2-459f-965e-0ec29f189f1f	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	2deeee4f-b342-a178-e063-6394a90af897	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	Strides Pharma Science Limited	b8b76aaa-575b-497f-b854-c42bc992c784	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	St. Mary's Medical Park Pharmacy	02f87c60-8425-1a1e-e063-6294a90a0c94	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: DOXYCYCLINE HYCLATE generic name: DOXYCYCLINE HYCLATE
doxycycline hyclate	DOXYCYCLINE HYCLATE	Slate Run Pharmaceuticals, LLC	f31e69fc-e513-40e4-91b5-22ccf1ed9437	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: doxycycline hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	Acella Pharmaceuticals, LLC	3fb9f5ad-90a2-4858-bc34-f800d8b2fa90	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Doxycycline Hyclate generic name: DOXYCYCLINE HYCLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0145	doxycycline hyclate	doxycycline	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0148	doxycycline hyclate	doxycycline	Mylan Pharmaceuticals Inc	ANDA	Current