Application 079076

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 25MG BASE/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079076-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION			2016-06-09

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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	A079076-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2016-06-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079076-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2016-06-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079076-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2016-06-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079076-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079076-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079076-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079076-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079076-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079076-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079076-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079076-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079076-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079076-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079076-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079076-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079076-001	AP	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079076-001	AP	1	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranitidine Hydrochloride	RANITIDINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	7bf94bf7-fa11-70be-9f65-fe26a3db5a63	2018-11-21	Adverse reactions	Name fallback brand name: Ranitidine Hydrochloride generic name: RANITIDINE HYDROCHLORIDE
Acid Reducer	RANITIDINE HYDROCHLORIDE	WinCo Foods, LLC	70bc7062-ab3c-43eb-b524-0d8c6d1a674d	2014-12-10	Warnings	Name fallback generic name: RANITIDINE 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
67457-397	Ranitidine	Ranitidine	Mylan Institutional LLC	ANDA	Current
67457-397	Ranitidine	Ranitidine	Mylan Institutional LLC	ANDA	Current
67457-398	Ranitidine	Ranitidine	Mylan Institutional LLC	ANDA	Current
67457-398	Ranitidine	Ranitidine	Mylan Institutional LLC	ANDA	Current