Application 215630

Type: ANDA
Sponsor: VKT PHARMA

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
A215630-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-01-07
A215630-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215630-001	AB
A215630-002	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 2 · 64 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	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A215630-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215630-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215630-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215630-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215630-002	AB	1	`1c564ffb4f44…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a0f38398-4d34-4ecc-8a6a-37732adaaad3	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	HAWAII REPACK, INC.	eec89230-47fc-4139-a370-b4f9e225e8c0	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	e59a2c97-19c7-485c-bb1b-272ddb9ae053	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	e53928f3-5181-490b-acfb-be8d4cea60a9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	05b47b1d-f7f3-4dae-9b22-d43d2a7cfaef	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	ST. MARY'S MEDICAL PARK PHARMACY	febe39b1-9212-a281-e053-6394a90a1a9f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	b445a613-eaa8-45e8-be1f-5848bfd1dd36	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Preferred Pharmaceuticals Inc.	dbf94314-3a34-4f03-80b1-296559b7d6a5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	3ab235f4-da59-4a92-ad6b-c76cf3ecd985	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	9c5dce17-1865-4aa6-89f6-24dd55b5f06c	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	74a69baa-a7c5-4e67-8db6-2ec39ab6cfe5	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	7cef62ab-1740-4d0f-b6ea-fda783e1c197	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	3c32f8e2-f54a-422d-9c25-68692ea09001	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a3b50576-cd40-4f7e-9506-bd0a61988424	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	be69d9f9-f4ad-4cfe-bab2-e07186b25c1e	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630 ndc (product): 67877-842
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	a24e8f45-6ace-4a81-8005-c23a55dadd9a	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	NuCare Pharmceuticals,Inc.	fc603d56-6828-8c5e-e053-6394a90a35bd	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	077bb160-e616-4863-bdde-989140f99e1c	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	fd271deb-c748-bf26-e053-6294a90a11aa	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Asclemed USA, Inc.	69bd5340-298b-46ca-83c7-0b5ef233f9c5	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630

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
67877-842	FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	ANDA	Current
67877-843	FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	ANDA	Current