Application 050006

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIBRAMYCIN	DOXYCYCLINE	FOR SUSPENSION;ORAL	EQ 25MG BASE/5ML	Yes	Yes

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
N050006-001	VIBRAMYCIN	DOXYCYCLINE	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050006-001	VIBRAMYCIN	EQ 25MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050006-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050006-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050006-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050006-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050006-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050006-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050006-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050006-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050006-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050006-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050006-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050006-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050006-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050006-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050006-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050006-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050006-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050006-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050006-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050006-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050006-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050006-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050006-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050006-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050006-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050006-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050006-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050006-001	AB	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 5 · 98 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxycycline	DOXYCYCLINE	Safecor Health, LLC	f02f5358-dd42-44d7-802d-a3001e0d4f13	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Coupler LLC	595470f9-2004-c378-e063-6294a90a3415	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	NuCare Pharmaceuticals,Inc.	2a07049d-3950-d293-e063-6294a90a4450	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	f0fbf63a-e75c-40cf-b2e9-429deaac899d	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Avenacy Inc.	429813b4-0223-4d85-a844-b1227ff63b1e	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	A-S Medication Solutions	fe8cd3c6-36d6-4d92-bc5c-833cd6f9cb32	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	Lupin Pharmaceuticals, Inc.	2946fc05-78e5-4669-85d1-3a3979eceae0	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Proficient Rx LP	d9388b32-dcb8-4dff-8a35-8fccb31bd1f8	2026-08-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	bcc95094-80ed-4023-b2a6-955a4810bfbe	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Wellhouse Pharma, LLC	57f97f68-11fb-4900-9efb-ca3b00818d8e	2026-07-24	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Bryant Ranch Prepack	04de98f3-33a2-48ba-85b5-9fac867524b7	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Golden State Medical Supply, Inc.	e9997efa-9ad8-3870-e053-2a95a90a1ac3	2026-07-06	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
DOXYCYCLINE	DOXYCYCLINE	REMEDYREPACK INC.	fa2d9328-b688-47af-8c4d-dc328cf35392	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Strides Pharma Science Limited	9e710113-f25e-46fb-8327-7a8e649613a2	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	A-S Medication Solutions	55873d3e-09c4-4726-acfe-5da581589575	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	REMEDYREPACK INC.	d3c0b756-30ba-4ef9-a178-fd785d720373	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	ST. MARY'S MEDICAL PARK PHARMACY	00b2aa98-dea2-90c3-e063-6294a90a35d6	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	American Health Packaging	e49f8ff9-af7a-47eb-929b-238cff381c03	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
doxycycline	DOXYCYCLINE	Preferred Pharmaceuticals Inc.	7f882f1a-fe75-4592-9df5-f0e4bf1d232e	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE
Doxycycline	DOXYCYCLINE	Meitheal Pharmaceuticals Inc.	7772e702-20b3-473a-8bd5-9c7c92e753c6	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: DOXYCYCLINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div P	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0970	Vibramycin Monohydrate	doxycycline	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83082	SUPPL	2025-08-12
83078	SUPPL	2025-08-11
81844	SUPPL	2025-04-08
81788	SUPPL	2025-04-02
61436	SUPPL	2019-12-26
61408	SUPPL	2019-12-23
56668	SUPPL	2018-12-07
56626	SUPPL	2018-12-04
49110	SUPPL	2017-07-28
49091	SUPPL	2017-07-27
46588	SUPPL	2016-12-29
46504	SUPPL	2016-12-21
38905	SUPPL	2016-04-07
29971	SUPPL	2016-04-05
38904	SUPPL	2014-10-02
7684	SUPPL	2014-09-16
17790	SUPPL	2013-09-09
7683	SUPPL	2013-09-09
17789	SUPPL	2013-05-01
7682	SUPPL	2013-04-30
38903	SUPPL	2011-05-16
17788	SUPPL	2008-02-14
29970	SUPPL	2008-02-13
29969	SUPPL	2004-03-16
29968	SUPPL	2002-06-18