FDA.reportPublic FDA data

Application 217078

Type
ANDA
Sponsor
PRECISION DOSE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEINJECTABLE;INJECTIONEQ 100MG BASE/VIALNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217078-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217078-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217078-001DOXYCYCLINE HYCLATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2025-02-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217078-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A217078-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217078-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217078-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217078-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217078-001AP1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217078-001AP1a50c72e98297…

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 8 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP2993ac3d-0ec4-4230-858e-9fd00063cf572022-04-01Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP3303b423-b270-495b-9360-e43144fcf6f22021-04-01Warnings, Adverse reactionsName fallback
brand name: doxycycline hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATESonoma Pharmaceuticals, Inc.4fa26176-a730-48ed-9659-e2f64212f4182018-05-23Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATENovel Laboratories, Inc.25a92544-1421-4ccb-a49c-11742851f2142018-03-12Warnings, Adverse reactionsName fallback
brand name: Doxycycline Hyclate
generic name: DOXYCYCLINE HYCLATE
Acticlate CAPDOXYCYCLINE HYCLATEAqua Pharmaceuticals5e96d473-63dd-4446-88cf-eef2cd3339f02017-11-28Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.