Application 080571

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	No
002	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/ML	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
A080571-001	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A080571-002	THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	200MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080571-001	AP

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A080571-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION		Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080571-002	THIAMINE HYDROCHLORIDE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080571-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION		Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080571-002	THIAMINE HYDROCHLORIDE	200MG/ML	INJECTABLE / INJECTION		Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080571-001	THIAMINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080571-002	THIAMINE HYDROCHLORIDE	200MG/ML	INJECTABLE / INJECTION		RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080571-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080571-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080571-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080571-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080571-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080571-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080571-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080571-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080571-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080571-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080571-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080571-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080571-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080571-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080571-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080571-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080571-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080571-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080571-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080571-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080571-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080571-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080571-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080571-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080571-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THIAMINE HYDROCHLORIDE injection, solution	THIAMINE HYDROCHLORIDE INJECTION, SOLUTION	HF Acquisition Co LLC, DBA HealthFirst	06446e9a-0e85-0623-e063-6294a90ac403	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080571 application number: ANDA080571
THIAMINE HYDROCHLORIDE	THIAMINE HYDROCHLORIDE	Henry Schein, Inc.	3bdf3b03-90cf-4416-9344-7733b193adf5	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080571 application number: ANDA080571
Thiamine Hydrochloride	THIAMINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	43926cec-e483-8cf1-4d8d-5145e554d45d	2022-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080571 application number: ANDA080571

Reported adverse events (FAERS/openFDA)#

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