Application 019901

Type: NDA
Sponsor: KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALTACE	RAMIPRIL	CAPSULE;ORAL	1.25MG	Yes	No
002	ALTACE	RAMIPRIL	CAPSULE;ORAL	2.5MG	Yes	No
003	ALTACE	RAMIPRIL	CAPSULE;ORAL	5MG	Yes	No
004	ALTACE	RAMIPRIL	CAPSULE;ORAL	10MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019901-001	ALTACE	RAMIPRIL	1.25MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-002	ALTACE	RAMIPRIL	2.5MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-003	ALTACE	RAMIPRIL	5MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-004	ALTACE	RAMIPRIL	10MG	CAPSULE / ORAL	RLD	1991-01-28

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019901-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019901-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019901-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019901-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019901-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019901-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019901-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019901-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019901-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019901-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019901-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019901-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019901-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019901-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019901-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019901-004	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019901-001	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-002	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-003	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-004	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N019901-001	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-002	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-003	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-004	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019901-001	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-002	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-003	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-004	7368469	2020-08-30	U-871	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019901-001	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-002	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-003	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-004	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019901-001	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-002	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-003	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-004	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019901-001	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-002	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-003	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-004	7368469	2020-08-30	U-871	`ea99ee380514…`

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 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Bryant Ranch Prepack	3806abdc-6aec-4252-bd79-e2c115b849aa	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Aurobindo Pharma Limited	d6d57158-e8f9-4c91-8317-0374e0c87d33	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Lupin Pharmaceuticals, Inc.	a8cdec12-81d1-4ef4-82c0-d05d93c37a07	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Zydus Pharmaceuticals USA Inc.	055bb582-67cd-425a-8823-d543c14305ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	ef05b44e-4bf7-4afa-a5f6-06efa0d0abc3	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	8be00433-3113-437e-8ab6-721af4d79185	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Bryant Ranch Prepack	d270b634-0d6d-4614-b223-a2af1e238c2f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Hikma Pharmaceuticals USA Inc.	7e9e84f7-ff47-463d-bf47-7a9745960aae	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	f6c86139-b1f7-4e84-944f-94af883ce4ea	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	fcf42121-8e85-4eae-82b4-bc029653b462	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	NuCare Pharmaceuticals, Inc.	4bd2d586-6851-4a40-e063-6394a90a0cab	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	REMEDYREPACK INC.	394a49a8-81bb-43ba-8d6a-fa6fa5030587	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	e8d9a115-71a7-4580-abbd-865e98b5d3f6	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	d856fb57-f1a0-49e6-bb2d-b4924af48515	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	A-S Medication Solutions	a3786664-a1b5-4914-99d6-79fb0e330e98	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Chartwell RX, LLC.	b7e49f05-6d4f-465a-b0d7-f704466a2e52	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2b87655-93c3-16a5-e053-2a95a90a593c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab3124b7-deed-8e04-e053-2a95a90a3b85	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2f325b8-f33d-3b93-e053-2995a90aa660	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f7e61b5b-fb5b-ba15-e053-6394a90adc3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RAMIPRIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61570-110	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-110	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-110	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-110	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-111	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-111	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-111	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-111	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-112	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-112	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-112	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-112	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-120	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-120	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-120	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current
61570-120	ALTACE	ramipril	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85925	SUPPL	2026-05-18
85863	SUPPL	2026-05-11
48204	SUPPL	2017-05-02
48127	SUPPL	2017-04-27
34086	SUPPL	2015-09-14
19824	SUPPL	2015-09-14
34085	SUPPL	2014-05-06
1796	SUPPL	2014-05-06
1795	SUPPL	2013-11-06
34084	SUPPL	2013-11-04
11833	SUPPL	2013-10-31
19823	SUPPL	2013-10-28
19822	SUPPL	2013-09-24
34083	SUPPL	2013-09-23
11832	SUPPL	2012-04-20
1794	SUPPL	2012-04-16
11831	SUPPL	2011-09-02
19821	SUPPL	2011-08-26
20418	SUPPL	2011-02-15
19820	SUPPL	2010-10-25
11830	SUPPL	2010-10-25
19818	SUPPL	2009-03-06
19819	SUPPL	2009-02-18
44039	ORIG	2006-06-09
20417	SUPPL	2005-04-15
19817	SUPPL	2004-11-16
1793	SUPPL	2004-10-22
1792	SUPPL	2004-10-22
1791	SUPPL	2004-10-22
1790	SUPPL	2002-08-02
19816	SUPPL	2002-07-10
20416	SUPPL	1998-12-16