Application 020958

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	TABLET, CHEWABLE;ORAL	800MG;10MG;165MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020958-001	PEPCID COMPLETE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL		RLD, RS	2000-10-16

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020958-001	PEPCID COMPLETE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	RLD, RS	2000-10-16	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020958-001	6814978	2021-08-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020958-001	6814978	2021-08-26	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020958-001	6814978	2021-08-26	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020958-001	6814978	2021-08-26	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020958-001	6814978	2021-08-26	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020958-001	6814978	2021-08-26	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020958-001	6814978	2021-08-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020958-001	6814978	2021-08-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020958-001	6814978	2021-08-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020958-001	6814978*PED	2022-02-26	Pediatric extension	`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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Kenvue Brands LLC	a2ef8424-7d80-42b0-a01e-f378f629b2b6	2026-07-24	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 16837-891
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Select Consumer Group	55cc3304-9094-3da8-e063-6394a90aa49b	2026-07-04	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Savings Distributors LLC	549136d5-8f2c-d417-e063-6394a90a23e4	2026-06-01	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Kenvue Brands LLC	e874118f-b4fe-4c80-aece-99ea20e7e805	2026-03-12	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 16837-298
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	R J General Corporation	f0e08608-e9b0-3203-e053-2995a90adfbd	2025-11-17	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 70264-034
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Kenvue Brands LLC	37e6a3f6-5261-475d-a7d4-e72854088982	2025-11-05	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 16837-246
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Morning Star OTC	be7f97d5-d2f2-45a8-96b4-fed1549ae2a3	2025-06-19	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	39f7ee67-4eab-42b0-82fc-40dc8ce7666b	2024-12-31	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 50269-016
DUAL ACTION Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLE	Lil' Drug Store Products, Inc.	f3cf2e19-1348-0eac-e053-2a95a90a46c1	2024-12-30	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	Navajo Manufacturing Company Inc	ac3cd760-4615-117b-e053-2a95a90a8d42	2024-04-15	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 67751-202
Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE CHEWABLE TABLET	Lil' Drug Store Products, Inc.	d08984b8-ce03-9e95-e053-2995a90ae6f0	2024-01-25	Warnings	Exact identifier application applno (NDA): 020958 application number: NDA020958 ndc (product): 66715-9822

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-246	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-298	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-891	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50269-016	Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
50269-016	Pepcid Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	JC World Bell Wholesale Co., Inc.	NDA	Current
52904-948	Pepcid Complete	Famotidine, Calcium Carbonate, and Magnesium Hydroxide	Select Corporation	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
66715-9822	Pepcid Complete	Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet	Lil' Drug Store Products, Inc.	NDA	Current
67751-202	Pepcid Complete	Famotidine, Calcium carbonate, and Magnesium hydroxide	Navajo Manufacturing Company Inc	NDA	Current
70264-034	Pepcid Complete	famotidine, calcium carbonate, and magnesium hydroxide	R J General Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83628	SUPPL	2025-10-02
83626	SUPPL	2025-10-02
81234	SUPPL	2025-02-12
81221	SUPPL	2025-02-12
81114	SUPPL	2025-02-06
81036	SUPPL	2025-02-06
80898	SUPPL	2025-02-04
80897	SUPPL	2025-02-04
59095	SUPPL	2019-06-17
59041	SUPPL	2019-06-12
58339	SUPPL	2019-04-16
58331	SUPPL	2019-04-15
57083	SUPPL	2018-12-31
57051	SUPPL	2018-12-21
35720	SUPPL	2016-06-14
26300	SUPPL	2016-06-14
35719	SUPPL	2013-09-19
26299	SUPPL	2013-08-01
41841	SUPPL	2012-03-27
3850	SUPPL	2008-11-18
41840	SUPPL	2007-06-18
3849	SUPPL	2006-06-12
13815	SUPPL	2005-07-21
3848	SUPPL	2005-07-21
26298	SUPPL	2004-10-29
3847	SUPPL	2003-11-13
41839	ORIG	2003-09-25
13814	SUPPL	2003-04-25
13813	ORIG	2000-10-16
3846	ORIG	2000-10-16