Application 075718

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	20MG	No	No
002	FAMOTIDINE	FAMOTIDINE	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075718-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2001-04-16
A075718-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075718-001	AB
A075718-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075718-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075718-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2001-04-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075718-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075718-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075718-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075718-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075718-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075718-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075718-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075718-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075718-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075718-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075718-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075718-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075718-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075718-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075718-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075718-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075718-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075718-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075718-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075718-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075718-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075718-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075718-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075718-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075718-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075718-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075718-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075718-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075718-002	AB	1	`782e0a99824c…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Sportpharm LLC	4421ceb7-a114-436c-871a-7bc5444f8154	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Proficient Rx LP	68d21d95-9603-4e68-855a-bfc65b1b58c3	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	5d515c2a-dac9-42d8-aede-66d28a427dbc	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Cardinal Health 107, LLC	cdd5dfb7-4efb-4235-8023-5ce145c09038	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	545d5c1f-ec1c-4135-965f-333ad888d96f	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (product): 71335-1950
Famotidine	FAMOTIDINE	Legacy Pharmaceutical Packaging, LLC	cc88fbdc-546e-332f-e053-2995a90a8ca7	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (product): 68645-594
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	5ed77259-5dd9-4634-a073-346693488c4f	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Major Pharmaceuticals	3e6d167f-91e4-4122-911d-d3da66386f44	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (product): 0904-7193
Famotidine	FAMOTIDINE	AvPAK	dfdca61d-8824-6230-e053-2995a90a209d	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (product): 50268-299
Famotidine	FAMOTIDINE	Quality Care Products, LLC	3549386a-533d-4e44-8097-f6bc51ee494a	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Direct_Rx	138d9ed1-2f8f-d19d-e063-6394a90a695d	2024-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718
Famotidine	FAMOTIDINE	Dr.Reddy's Laboratories Limited	06d286ce-14b3-4b66-8b42-ac4a10a0fc90	2020-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075718 application number: ANDA075718 ndc (product): 55111-119 ndc (product): 55111-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7193	Famotidine	Famotidine	Major Pharmaceuticals	ANDA	Current
0904-7193	Famotidine	Famotidine	Major Pharmaceuticals	ANDA	Current
50268-299	Famotidine	Famotidine	AvPAK	ANDA	Current
55111-119	Famotidine	Famotidine	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-119	Famotidine	Famotidine	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-120	Famotidine	Famotidine	Dr.Reddy's Laboratories Limited	ANDA	Current
55111-120	Famotidine	Famotidine	Dr.Reddy's Laboratories Limited	ANDA	Current
63739-325	FAMOTIDINE	Famotidine	McKesson Corporation	ANDA	Current
68071-2678	Famotidine	Famotidine	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-0184	Famotidine	Famotidine	Carilion Materials Management	ANDA	Current
68645-594	Famotidine	Famotidine	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-9220	Famotidine	Famotidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1950	Famotidine	Famotidine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30998	ORIG	2001-04-16