Application 064210

Type: ANDA
Sponsor: XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STREPTOMYCIN SULFATE	STREPTOMYCIN SULFATE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	Yes

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
A064210-001	STREPTOMYCIN SULFATE	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RS	1998-06-30

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064210-001	STREPTOMYCIN SULFATE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RS	1998-06-30	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Streptomycin	STREPTOMYCIN	XGen Pharmaceuticals DJB, Inc.	abd1f64e-4283-4370-aae8-3666316aa36e	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064210 application number: ANDA064210 ndc (product): 39822-0706

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
39822-0706	Streptomycin	Streptomycin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0706	Streptomycin	Streptomycin	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0706	Streptomycin	Streptomycin	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-0706	Streptomycin	Streptomycin	XGen Pharmaceuticals DJB, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39412	SUPPL	2012-07-30
8358	ORIG	1998-06-30