Application 209452

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	POWDER FOR ORAL SOLUTION	100MG/PACKET	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
A209452-001	SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	FOR SOLUTION / ORAL	AB		2021-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209452-001	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.

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	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER / ORAL	AB	2021-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209452-001	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	FOR SOLUTION / ORAL	AB	2021-03-30	`a50c72e98297…`

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	A209452-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209452-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209452-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209452-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209452-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209452-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209452-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209452-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209452-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209452-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209452-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209452-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209452-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209452-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209452-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209452-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209452-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209452-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209452-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209452-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209452-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209452-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209452-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209452-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209452-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209452-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209452-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209452-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209452-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209452-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209452-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209452-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209452-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209452-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAVYGTOR	SAPROPTERIN DIHYDROCHLORIDE	Dr. Reddys Laboratories Inc	1590afa1-baa4-70e5-5a3b-468401c71044	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209452 application number: ANDA209452 ndc (product): 43598-097

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
43598-097	JAVYGTOR	Sapropterin Dihydrochloride	Dr. Reddys Laboratories Inc	ANDA	Current
43598-477	Sapropterin Dihydrochloride	Sapropterin Dihydrochloride	Dr. Reddys Laboratories Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50991	ORIG	2020-03-17