FDA.reportPublic FDA data

Application 065055

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 100MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 150MG BASENoYes
004DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065055-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01
A065055-002DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01
A065055-003DOXYCYCLINEDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15
A065055-004DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065055-001AB
A065055-002AB
A065055-003AB

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
2026-08-01 22:54:322026-06A065055-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORALAB2000-12-01a50c72e98297…
2026-08-01 22:54:322026-06A065055-002DOXYCYCLINEEQ 100MG BASECAPSULE / ORALAB2000-12-01a50c72e98297…
2026-08-01 22:54:322026-06A065055-003DOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRS2005-07-15a50c72e98297…
2026-08-01 22:54:322026-06A065055-004DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2005-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065055-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A065055-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
ndc (product): 51407-678
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
ndc (product): 64380-180
ndc (product): 64380-179
ndc (product): 64380-181
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
ndc (product): 60687-716
DoxycyclineDOXYCYCLINEBryant Ranch Prepack6285181d-e34d-4def-abe6-2c41254ada752026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINENuCare Pharmaceuticals,Inc.fa1da527-7a0f-8ed6-e053-6394a90a1b622024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEProficient Rx LPc707566b-dbc7-4dac-bad1-952f2f4d68452024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055
DoxycyclineDOXYCYCLINEA-S Medication Solutions6aab6fee-791e-4141-b55f-685ec9d8712a2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065055
application number: ANDA065055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10337-815AdoxadoxycyclinePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical SupplyANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical SupplyANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
51407-678DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
55700-323DoxycyclinedoxycyclineLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-716DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
63187-135DoxycyclinedoxycyclineProficient Rx LPANDACurrent
63187-135DoxycyclinedoxycyclineProficient Rx LPANDACurrent
63629-2183DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-2183DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-6637DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-8212DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-8212DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
64380-179DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
64380-180DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
64380-181DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
67296-1025DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1025DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0221DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0221DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
76519-1206DOXYCYCLINEDOXYCYCLINEH.J. Harkins Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18325SUPPL2014-07-30
30641SUPPL2014-07-24
18324SUPPL2014-02-06
30640ORIG2000-12-01