Application 212635

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	250MG	No	No
002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212635-001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		2020-03-03
A212635-002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB		2020-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212635-001	AB
A212635-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212635-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	2020-03-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212635-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	2020-03-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212635-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212635-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212635-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212635-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212635-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212635-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212635-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212635-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212635-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212635-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212635-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212635-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212635-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212635-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212635-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212635-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212635-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212635-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212635-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212635-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212635-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212635-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212635-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212635-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212635-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212635-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212635-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212635-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212635-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212635-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212635-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212635-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212635-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212635-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212635-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212635-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212635-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212635-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212635-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212635-002	AB	1	`bb7c543d1eb4…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	4ac5177d-bb67-45e6-adcf-44f0821746bd	2024-08-01	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	2c9208db-5f4f-4382-854f-6786b1e458db	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Pharmaka Generics Inc.	c522c860-84ce-4c61-ab72-077de73195df	2024-01-17	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE HYDROCHLORIDE
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Name fallback generic name: TETRACYCLINE HYDROCHLORIDE
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Chartwell RX, LLC.	aa30113f-ab58-4f41-82c1-2fcb540d4a82	2023-07-19	Warnings, Adverse reactions	Name fallback brand name: Tetracycline Hydrochloride generic name: TETRACYCLINE 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-890	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-890	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-891	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current
64380-891	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	ANDA	Current